Phase 2
Completed N=77
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Source: ClinicalTrials.gov NCT00573469 ↗Enrolled (actual)
77
Serious AEs
5.2%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment — 6; 7; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment |
6; 7; 3 | — |
| SECONDARY Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment |
2; 3; 0 | — |
| SECONDARY Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment |
5; 6; 3 | — |
| SECONDARY Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method |
38.5; 36.0; 19.0 | — |
| SECONDARY Change in CDAI Score From Baseline to 8 Weeks |
-48; -58; -27 | — |
Eligibility Criteria
Inclusion Criteria
- Female or male aged ≥ 18 and ≤ 65 years
- Diagnosis of Crohn's Disease
Exclusion Criteria
- Having ileostomy or pouch and/or colostomy
- Having previous gastric surgery
- Having a known or suspected systemic infection
Data sourced from ClinicalTrials.gov (NCT00573469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.