At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
D9421-C, 9mg +2 moredrug
Likely dose
D9421-C, 9mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating D9421-C, 9mg, D9421-C, 15mg, and 1 other intervention for Crohn's Disease. Completed, enrolled 75 participants across 22 sites.
Detailed Summary
The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedDec 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedDec 14, 2007
Enrollment StartOct 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.6 years ago
Interventions
D9421-C, 9mgdrug
D9421-C 9 mg was given once daily for 8 weeks.
D9421-C, 15mgdrug
D9421-C 15 mg was given once daily for 8 weeks.
Placebodrug
D9421-C matching placebo was given once daily for 8 weeks.