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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: D9421-C, 9mg; Drug: D9421-C, 15mg; Drug: Placebo

• Registration Number: NCT00573469
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-18
• Results First Submitted QC: 2012-01-19
• Results First Posted: 2012-02-24
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-02
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Female or male aged ≥ 18 and ≤ 65 years
• Diagnosis of Crohn's Disease

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Exclusion Criteria

• Having ileostomy or pouch and/or colostomy
• Having previous gastric surgery
• Having a known or suspected systemic infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	D9421-C, 9mg	D9421-C 9 mg
2	D9421-C, 15mg	D9421-C 15 mg
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment	Baseline to 8 weeks	Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment	Baseline to 2 weeks	The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.
Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment	Baseline to 4 weeks	The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.
Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method	At 8 weeks	Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.
Change in CDAI Score From Baseline to 8 Weeks	Baseline to 8 weeks	CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Toyama, Japan