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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573469
• Other study ID #: D9421C00002
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2007
• Last updated: July 2, 2012
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• D9421-C, 9mg
D9421-C 9 mg was given once daily for 8 weeks.
• D9421-C, 15mg
D9421-C 15 mg was given once daily for 8 weeks.
• Placebo
D9421-C matching placebo was given once daily for 8 weeks.

Locations

Country	Name	City	State
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Chikushino	Fukuoka
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Hashima-gun	Gifu
Japan	Research Site	Hiroshima
Japan	Research Site	Itami
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kurashiki	Okayama
Japan	Research Site	Kurume	Fukuoka
Japan	Research Site	Kyoto
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Nishinomiya
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Sakura	Chiba
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Shinjuku-ku	Tokyo
Japan	Research Site	Suita	Osaka
Japan	Research Site	Tokorozawa	Saitama
Japan	Research Site	Tokyo
Japan	Research Site	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment	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.	Baseline to 8 weeks	No
Secondary	Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment	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.	Baseline to 2 weeks	No
Secondary	Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment	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.	Baseline to 4 weeks	No
Secondary	Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method	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.	At 8 weeks	No
Secondary	Change in CDAI Score From 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.	Baseline to 8 weeks	No