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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:
ClinicalTrials.gov Identifier:
NCT00573469
First Posted: December 14, 2007
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00573469     History of Changes
Other Study ID Numbers: D9421C00002
First Submitted: December 13, 2007
First Posted: December 14, 2007
Results First Submitted: March 18, 2009
Results First Posted: February 24, 2012
Last Update Posted: July 12, 2012
Last Verified: July 2012

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