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Completed

NCT Number: NCT00573469

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D9421-C, 9mg

Drug

D9421-C 9 mg was given once daily for 8 weeks.

D9421-C, 15mg

Drug

D9421-C 15 mg was given once daily for 8 weeks.

Placebo

Drug

D9421-C matching placebo was given once daily for 8 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 14, 2007
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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