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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00573469
First received: December 13, 2007
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Drug: D9421-C, 9mg
Drug: D9421-C, 15mg
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
D9421-C 9 mg
 Drug: D9421-C, 9mg
D9421-C 9 mg was given once daily for 8 weeks.
Active Comparator: 2
D9421-C 15 mg
 Drug: D9421-C, 15mg
D9421-C 15 mg was given once daily for 8 weeks.
Placebo Comparator: 3
Placebo
 Drug: Placebo
D9421-C matching placebo was given once daily for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573469

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Sakura, Chiba, Japan
Research Site
Chikushino, Fukuoka, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Hashima-gun, Gifu, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kurashiki, Okayama, Japan
Research Site
Suita, Osaka, Japan
Research Site
Tokorozawa, Saitama, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Itami, Japan
Research Site
Kyoto, Japan
Research Site
Nishinomiya, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Research Site
Toyama, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Masataka Date, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00573469     History of Changes
Other Study ID Numbers: D9421C00002
Study First Received: December 13, 2007
Results First Received: March 18, 2009
Last Updated: July 2, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
gastrointestinal
GI
Crohn's disease
Japan
Japanese

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013