Lt-02    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis23

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
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.
23 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02849951
(ClinicalTrials.gov)
July 201626/7/2016A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With MesalamineUlcerative ColitisDrug: LT-02;Drug: LT-02 PlaceboPrometheus LaboratoriesNestlé Health Science Spain;INC ResearchTerminated18 Years70 YearsAll25Phase 3United States
2EUCTR2013-001205-84-BE
(EUCTR)
11/03/201617/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
3EUCTR2013-001205-84-HU
(EUCTR)
07/03/201604/01/2016LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
4EUCTR2013-001205-84-AT
(EUCTR)
13/10/201502/09/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
5EUCTR2013-001205-84-SK
(EUCTR)
23/03/201505/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-001205-84-LV
(EUCTR)
26/02/201523/12/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands
7EUCTR2013-001205-84-PL
(EUCTR)
20/01/201522/09/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
8EUCTR2013-001205-84-DE
(EUCTR)
13/01/201508/08/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
9EUCTR2012-003702-27-BE
(EUCTR)
21/10/201404/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
10NCT02280629
(ClinicalTrials.gov)
October 1, 201429/10/2014Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: LT-02;Drug: Placebo;Drug: MesalamineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsAll150Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-003702-27-NL
(EUCTR)
30/09/201414/04/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
12EUCTR2012-003702-27-PL
(EUCTR)
29/07/201420/05/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
13NCT02142725
(ClinicalTrials.gov)
July 21, 201415/5/2014Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative ColitisRandomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With MesalamineUlcerative ColitisDrug: LT-02;Drug: PlaceboDr. Falk Pharma GmbHNULLTerminated18 Years70 YearsAll468Phase 3Germany
14EUCTR2012-003702-27-SK
(EUCTR)
10/06/201406/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
15EUCTR2012-003702-27-LV
(EUCTR)
20/05/201425/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-003702-27-HU
(EUCTR)
19/05/201407/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands
17EUCTR2012-003702-27-CZ
(EUCTR)
15/05/201424/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
18EUCTR2012-003702-27-LT
(EUCTR)
12/05/201419/03/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
19EUCTR2012-003702-27-DE
(EUCTR)
08/05/201430/12/2013LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
20EUCTR2012-003702-27-AT
(EUCTR)
02/04/201410/02/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01011322
(ClinicalTrials.gov)
December 200910/11/2009A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative ColitisUlcerative Colitis;Large Intestine;Diarrhea;Abdominal PainDrug: LT-02;Drug: placeboLipid Therapeutics GmbHNULLActive, not recruiting18 YearsN/ABoth156Phase 2Germany;Lithuania;Romania
22EUCTR2008-007952-90-LT
(EUCTR)
23/11/200915/09/2009A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Lipid Therapeutics GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2bGermany;Lithuania
23EUCTR2008-007952-90-DE
(EUCTR)
17/11/200904/08/2009A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Lipid Therapeutics GmbHNULLNot RecruitingFemale: yes
Male: yes
240Phase 2bGermany;Lithuania