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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
D9421-C 9 mg was given once daily for 8 weeks.
D9421-C 15 mg was given once daily for 8 weeks.
D9421-C matching placebo was given once daily for 8 weeks.
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Sakura, Chiba, Japan
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.
Time frame: Baseline to 8 weeks
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.
Time frame: Baseline to 2 weeks
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.
Time frame: Baseline to 4 weeks
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.
Time frame: At 8 weeks
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.
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Research Site
Chikushino-shi, Fukuoka, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Hashima-gun, Gifu, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
...and 12 more locations
Time frame: Baseline to 8 weeks