96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209

  
64 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022383-12-BG
(EUCTR)
13/06/201320/05/2013A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
2EUCTR2010-022384-35-BG
(EUCTR)
13/06/201328/05/2013A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
3EUCTR2011-002817-12-BG
(EUCTR)
03/06/201320/05/2013A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand
4EUCTR2011-002817-12-NL
(EUCTR)
19/04/201307/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Germany;Norway;Japan;New Zealand;Sweden
5EUCTR2011-002817-12-DE
(EUCTR)
05/02/201306/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
6EUCTR2011-002817-12-CZ
(EUCTR)
09/01/201308/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseRandomizované, dvojite zaslepené klinické hodnocení aktivní lécby pro navození klinické odpovedi a/nebo remise pri podávání GSK1605786A pacientum se stredne težkou až težkou aktivní Crohnovou chorobou. Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand
7EUCTR2011-002817-12-DK
(EUCTR)
19/12/201230/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden
8EUCTR2011-002817-12-HU
(EUCTR)
13/12/201206/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
9EUCTR2010-022382-10-AT
(EUCTR)
10/07/201224/04/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden
10EUCTR2010-022382-10-ES
(EUCTR)
20/06/201211/05/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn's Disease Subjects with Moderately-to-Severely Active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Norway;Netherlands;Germany;New Zealand;Japan;Sweden;Korea, Republic of
11EUCTR2010-022382-10-SK
(EUCTR)
22/05/201212/04/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden
12EUCTR2010-022384-35-SK
(EUCTR)
16/05/201213/04/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
13EUCTR2011-002817-12-SK
(EUCTR)
19/04/201213/04/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Germany;France;Hong Kong;Austria;Sweden;South Africa;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Hungary;Switzerland;Netherlands;Chile;Norway;Italy;Israel;United Kingdom;Russian Federation;Slovakia;Ukraine;Taiwan;Denmark;Argentina;Estonia;China;Spain;Japan
14EUCTR2011-002817-12-PT
(EUCTR)
29/03/201218/01/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
15EUCTR2010-022384-35-PT
(EUCTR)
29/03/201218/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
16EUCTR2010-022383-12-PT
(EUCTR)
29/03/201218/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
17EUCTR2010-022384-35-IT
(EUCTR)
28/03/201202/03/2012A 25 month study of a potential new medicine (GSK1605786A) for thetreatment of Crohn's diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A inSubjects with Crohn's Disease - Open label extension study Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden
18EUCTR2010-022382-10-IT
(EUCTR)
28/03/201202/03/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to-Severely Active Crohn's Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to Severely Active Crohn's Disease Subjects with Moderately-to-Severely Active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;South Africa;Norway;Germany;Netherlands;Japan;New Zealand;Sweden
19EUCTR2010-022383-12-IT
(EUCTR)
28/03/201202/03/2012A 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Japan;Sweden
20EUCTR2010-022383-12-ES
(EUCTR)
27/03/201211/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
21EUCTR2011-002817-12-ES
(EUCTR)
27/03/201211/01/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's Disease Moderately-to-Severely Active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
22EUCTR2010-022384-35-ES
(EUCTR)
27/03/201211/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn's diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease - Open label extension study Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
23EUCTR2010-022384-35-AT
(EUCTR)
13/03/201227/12/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;New Zealand;Sweden
24EUCTR2010-022383-12-SK
(EUCTR)
07/03/201212/04/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
25EUCTR2010-022383-12-EE
(EUCTR)
01/03/201206/02/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
26EUCTR2010-022384-35-EE
(EUCTR)
01/03/201206/02/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
27EUCTR2011-002817-12-EE
(EUCTR)
01/03/201206/02/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Greece;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand
28EUCTR2010-022383-12-PL
(EUCTR)
15/02/201211/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
29EUCTR2010-022384-35-PL
(EUCTR)
15/02/201211/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
30EUCTR2011-002817-12-AT
(EUCTR)
26/01/201228/12/2011A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
31EUCTR2010-022383-12-AT
(EUCTR)
26/01/201229/12/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;Denmark;Australia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
32EUCTR2010-022383-12-GR
(EUCTR)
09/01/201214/12/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
33EUCTR2010-022384-35-GR
(EUCTR)
09/01/201227/12/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
34EUCTR2011-002817-12-GR
(EUCTR)
09/01/201214/12/2011A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
35EUCTR2010-022382-10-HU
(EUCTR)
14/12/201111/10/2011A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Japan;Sweden
36EUCTR2010-022383-12-HU
(EUCTR)
14/12/201111/10/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
37EUCTR2010-022384-35-HU
(EUCTR)
14/12/201111/10/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
38NCT01536418
(ClinicalTrials.gov)
November 11, 201116/2/2012An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786AGlaxoSmithKlineNULLTerminated18 YearsN/AAll255Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;China;Czech Republic;Ireland;South Africa
39EUCTR2010-022384-35-BE
(EUCTR)
30/05/201107/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
40EUCTR2010-022383-12-BE
(EUCTR)
30/05/201107/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
41EUCTR2010-022384-35-CZ
(EUCTR)
13/05/201131/03/2011An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s DiseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - SHIELD 3 Subjects with Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
42EUCTR2010-022383-12-CZ
(EUCTR)
12/05/201130/03/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease - SHIELD 2 Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
43NCT01316939
(ClinicalTrials.gov)
May 9, 20113/3/2011GSK1605786A in the Maintenance of Remission in Subjects With Crohn's DiseaseA 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786A;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 YearsN/AAll229Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland
44EUCTR2010-022384-35-DK
(EUCTR)
06/05/201101/04/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden
45EUCTR2010-022383-12-DK
(EUCTR)
08/04/201102/03/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
46NCT01318993
(ClinicalTrials.gov)
April 1, 20113/3/2011Open-Label Extension Study of GSK1605786AAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786AGlaxoSmithKlineNULLTerminated18 YearsN/AAll399Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;New Zealand;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland
47EUCTR2010-022384-35-GB
(EUCTR)
22/03/201130/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
48EUCTR2010-022384-35-SE
(EUCTR)
01/03/201115/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
49EUCTR2010-022383-12-SE
(EUCTR)
01/03/201115/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
50EUCTR2010-022383-12-GB
(EUCTR)
24/02/201123/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;Norway;Sweden
51EUCTR2010-022382-10-NL
(EUCTR)
16/02/201129/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: GSK1605786A
Product Code: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Spain;Belgium;Austria;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden
52EUCTR2010-022383-12-NL
(EUCTR)
16/02/201129/10/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
Other descriptive name: na
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden
53EUCTR2010-022382-10-BE
(EUCTR)
07/02/201107/12/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
54EUCTR2010-022384-35-DE
(EUCTR)
02/02/201110/11/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
55EUCTR2010-022382-10-SE
(EUCTR)
20/01/201109/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
56EUCTR2010-022382-10-DK
(EUCTR)
19/01/201110/12/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
57EUCTR2010-022382-10-DE
(EUCTR)
11/01/201122/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Japan;Sweden
58EUCTR2010-022383-12-NO
(EUCTR)
06/01/201102/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden
59EUCTR2010-022382-10-GB
(EUCTR)
06/01/201112/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
60EUCTR2010-022382-10-CZ
(EUCTR)
22/12/201004/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
61NCT01277666
(ClinicalTrials.gov)
December 20, 201013/1/2011A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's DiseaseA Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786A;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll608Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Czech Republic
62NCT01114607
(ClinicalTrials.gov)
May 5, 201029/4/2010A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy SubjectsA Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female SubjectsCrohn's DiseaseDrug: GSK1605786 ChemoCentryx: formulation A;Drug: GSK1605786 GSK: formulation B;Drug: GSK1605786 GSK direct-fill: formulation C;Drug: GSK1605786 GSK modified-process: formulation D;Drug: GSK1605786 GSK tablet: formulation EGlaxoSmithKlineNULLCompleted18 Years55 YearsAll24Phase 1United States
63EUCTR2010-022383-12-DE
(EUCTR)
02/11/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
64EUCTR2010-022382-10-NO
(EUCTR)
23/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: GSK1605786A
Product Code: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovakia;Spain;Austria;United Kingdom;Italy;Czech Republic;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden