Clinical trial
A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included.
NCT02209792 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included.
- Lead sponsor
- Boehringer Ingelheim
- Phase
- Phase 2
- Overall status
- Terminated
- Start date
- October 31, 2001
- Completion date
- Not reported
- Enrollment
- 284 (actual)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.