Back to resultsEfficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
D9421-C, 9mg
D9421-C, 15mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring gastrointestinal, GI, Crohn's disease, Japan, Japanese
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
D9421-C 9 mg
D9421-C 15 mg
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00573469
Brief Title
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
gastrointestinal, GI, Crohn's disease, Japan, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
D9421-C 9 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
D9421-C 15 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
D9421-C, 9mg
Intervention Description
D9421-C 9 mg was given once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
D9421-C, 15mg
Intervention Description
D9421-C 15 mg was given once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
D9421-C matching placebo was given once daily for 8 weeks.
Primary Outcome Measure Information:
Title
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment
Description
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.
Time Frame
Baseline to 2 weeks
Title
Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment
Description
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.
Time Frame
Baseline to 4 weeks
Title
Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method
Description
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.
Time Frame
At 8 weeks
Title
Change in CDAI Score From Baseline to 8 Weeks
Description
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.
Time Frame
Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masataka Date, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Sakura
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Hashima-gun
State/Province
Gifu
Country
Japan
Facility Name
Research Site
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Tokorozawa
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Itami
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nishinomiya
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan
Facility Name
Research Site
City
Toyama
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22766525
Citation
Suzuki Y, Motoya S, Takazoe M, Kosaka T, Date M, Nii M, Hibi T. Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study. J Crohns Colitis. 2013 Apr;7(3):239-47. doi: 10.1016/j.crohns.2012.06.006. Epub 2012 Jul 4.
Results Reference
derived
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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
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