stop_circleTerminated/Withdrawn
Colitis, Ulcerative
Bayer Identifier:
17155
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy/Safety pilot study to investigate Iberogast N's efficacy in mild to moderate colitis ulcerosa patients
Trial purpose
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
Key Participants Requirements
Sex
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
3Trial Dates
November 2014 - April 2016Phase
Phase 2Could I Receive a placebo
YesProducts
Iberogast N (STW5-II, BAY98-7410)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Essen, 45276, Germany | |
Terminated | Berlin, 14109, Germany | |
Terminated | Ludwigshafen, 67067, Germany | |
Completed | Dachau, 85221, Germany | |
Terminated | Köln, 50937, Germany | |
Terminated | Lübeck, 23538, Germany | |
Terminated | Lüneburg, 21339, Germany | |
Terminated | Hamburg, 20249, Germany |
Primary Outcome
- Proportion of patients being in remission at final visitResponder definition for remission: Clinical Activity Index (CAI) ≤ 4date_rangeTime Frame:Week 12enhanced_encryptionNoSafety Issue:
- Change of endoscopic index (EI)date_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Change of histological index (HI) based on Rileydate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Proportion of patients reaching a clinical CAI ≤ 2 pointsdate_rangeTime Frame:Week 12enhanced_encryptionNoSafety Issue:
- Time to remission, defined as days from Day 0 until first remission is reachedResponder definition for remission: Clinical Activity Index (CAI) ≤ 4date_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reacheddate_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Number of patients who reached a remission at least once during the course of the studydate_rangeTime Frame:Week 12enhanced_encryptionNoSafety Issue:
- Number of patients who reached a sustained remission at least once during the course of the studydate_rangeTime Frame:Week 12enhanced_encryptionNoSafety Issue:
- Change from baseline of absolute CAI values to final visitdate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visitdate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Change from baseline in Irritable Bowel Severity Score (IBSS) at final visitdate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visitdate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Mayo Score throughout the studydate_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change of of oral mesalazine dose throughout the study perioddate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
- Change in ulcerative colitis (UC) markersCombination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patientsdate_rangeTime Frame:From baseline to week 12enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2