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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Efficacy and safety study of D9421-C 9 mg and 15 mg versus placebo in Japanese patients with active Crohn's Disease

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

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

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.

Age, Customized

Gender, Male/Female

Number of participants who had remission of Crohn's disease after 8-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 2-week treatment

Number of participants who had remission of Crohn's disease after 4-week treatment

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.

Cumulative percentage of participants who achieved remission up to 8 weeks by Kaplan-Meier method

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.

Change in CDAI score from baseline to 8 weeks

Overall Study

Patients who had a CDAI score of less than 200 were excluded before randomisation.

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.

Efficacy and safety study of D9421-C 9 mg and 15 mg versus placebo in Japanese patients with active Crohn's Disease

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

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Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=433&filename=CSR-D9421C00002.pdf

CSR-D9421C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator