Phase 2 N=77 Randomized Double-blind Treatment

Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00573469 ↗

Enrolled (actual)

Serious AEs

5.2%

Results posted

Feb 2012

Primary outcome: Primary: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment — 6; 7; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: D9421-C, 9mg (Drug); D9421-C, 15mg (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2008

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	—

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.

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

View full record on ClinicalTrials.gov →

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.