96. Crohn disease
2,209 clinical trials,   1,276 drugs   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-002030-37-BE
(EUCTR)
08/01/201305/09/2012A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOTA DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT Crohn’s Disease (CD) and Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
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 Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
2EUCTR2010-024638-48-BG
(EUCTR)
26/09/201203/10/2012A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
3EUCTR2010-023437-30-BG
(EUCTR)
18/09/201217/07/2012Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
4EUCTR2010-023437-30-PL
(EUCTR)
06/06/201208/05/2012Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
5EUCTR2010-024638-48-PL
(EUCTR)
04/06/201209/05/2012A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United StatesNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01387594
(ClinicalTrials.gov)
May 201230/6/2011Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFsA Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative ColitisProcedure: lumbar puncture;Drug: lumbar punctureShireNULLCompleted18 Years75 YearsAll49Phase 1Austria;Belgium;France;Germany;Netherlands
7EUCTR2010-024638-48-BE
(EUCTR)
19/03/201225/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
8EUCTR2010-024638-48-DE
(EUCTR)
22/02/201230/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
9EUCTR2010-024638-48-NO
(EUCTR)
31/01/201201/06/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Serbia;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
10EUCTR2010-023437-30-NO
(EUCTR)
01/12/201101/06/2011Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Crohn's Disease
MedDRA version: 13.1;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Portugal;Germany;Netherlands;Norway;France;Austria;South Africa;Sweden;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-023437-30-DE
(EUCTR)
16/11/201126/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
MedDRA version: 18.0;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
12EUCTR2010-024638-48-NL
(EUCTR)
11/11/201108/06/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of
13EUCTR2010-023437-30-NL
(EUCTR)
11/11/201108/06/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's DiseaseA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden
14EUCTR2010-023437-30-SK
(EUCTR)
29/09/201111/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden
15EUCTR2010-024638-48-SK
(EUCTR)
29/09/201111/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-024638-48-PT
(EUCTR)
02/09/201126/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
17EUCTR2010-023437-30-PT
(EUCTR)
02/09/201126/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
18EUCTR2010-024638-48-ES
(EUCTR)
15/07/201118/11/2011A7281007; Multi-center open-label extension study for PF-00547659MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II 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: No aplicable
Product Code: PF-00547659
INN or Proposed INN: No aplicable
Other descriptive name: No aplicable
PFIZER, S.L.U.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
19NCT01298492
(ClinicalTrials.gov)
July 1, 201126/1/2011A Study To Monitor Long-Term Treatment With PF-00547659A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA IICrohn's DiseaseDrug: PF-00547659ShireNULLCompleted18 Years75 YearsAll268Phase 2United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden
20EUCTR2010-023437-30-ES
(EUCTR)
03/06/201113/06/2011Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERAEstudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Enfermedad de Crohn Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: PF-00547659
Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: No aplicable
PFIZER SLUNULLNot RecruitingFemale: yes
Male: yes
240Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-024638-48-SE
(EUCTR)
01/06/201125/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
22EUCTR2010-023437-30-SE
(EUCTR)
01/06/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
23EUCTR2010-023437-30-AT
(EUCTR)
01/06/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
24EUCTR2010-024638-48-AT
(EUCTR)
01/06/201125/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
25EUCTR2010-023437-30-BE
(EUCTR)
27/05/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA 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: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01276509
(ClinicalTrials.gov)
April 6, 201112/1/2011Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's DiseaseA Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)Crohn's DiseaseDrug: PF-00547659 SC injectionShireNULLCompleted18 Years75 YearsAll265Phase 2United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden