Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01514240
• Date of registration: 10/01/2012
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
• Scientific title: A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan
• Date of first enrolment: February 2012
• Target sample size: 123
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01514240
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Toshifumi Hibi, Professor, Chairman
• Affiliation: Department of Internal Medicine, Keio University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- 15 years of age or older

- Main active disease of the ileal, ileocecal region, and/or ascending colon - - If
treated with partial nutrition treatment (=1200 kcal/day) or if treated with
azathioprine (=2.0 mg/kg/day) or 6-mercaptopurine (=1.2 mg/kg/day), prior to
randomisation until the study completion or discontinuation

- Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to
moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

Exclusion Criteria:

- Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g.
lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis,
fistulae, ostomy, short bowel or other uncontrolled concomitant disease)

- Patient who need any concomitant treatment for CD that may affect the assessment for
efficacy of the study drug

- Patient who need any medication which is prohibited due to suspected influence to
metabolism of the study drug

- Patient who is judged to be inadequate to participate in this study from the safety
point of view Patient with well-founded doubt about protocol violation



Age minimum: 15 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: D9421-C capsule 3 mg

Drug: Mesalazine tablets

Primary Outcome(s)

Remission After 8-week of Treatment [Time Frame: 8 Week]

Secondary Outcome(s)

Change in IBDQ Scores From Baseline to Weeks 10 - Social Function [Time Frame: 10 Week]

Change in IBDQ Scores From Baseline to Weeks 2 - Social Function [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom [Time Frame: 8 Week]

Change in Observed CDAI Scores From Baseline to Weeks 2 [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function [Time Frame: 8 Week]

Change in Observed CDAI Scores From Baseline to Weeks 4 [Time Frame: 4 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 [Time Frame: 2 Week]

Cumulative Remission Rate at Week 2 [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function [Time Frame: 4 Week]

Change in IBDQ Scores From Baseline to Weeks 4 - Social Function [Time Frame: 4 Week]

Change in Total IBDQ Scores From Baseline to Weeks 4 [Time Frame: 4 Week]

Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom [Time Frame: 10 Week]

Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 8 - Social Function [Time Frame: 8 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 [Time Frame: 4 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 [Time Frame: 4 Week]

Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function [Time Frame: 10 Week]

Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function [Time Frame: 4 Week]

Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function [Time Frame: 8 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 [Time Frame: 8 Week]

Remission After 4-week of Treatment [Time Frame: 4 Week]

Change in Total IBDQ Scores From Baseline to Weeks 10 [Time Frame: 10 Week]

Cumulative Remission Rate at Week 8 [Time Frame: 8 Week]

Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom [Time Frame: 2 Week]

Remission After 2-week of Treatment [Time Frame: 2 Week]

Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function [Time Frame: 10 Week]

Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom [Time Frame: 4 Week]

Change in Observed CDAI Scores From Baseline to Weeks 8 [Time Frame: 8 Week]

Change in Total IBDQ Scores From Baseline to Weeks 2 [Time Frame: 2 Week]

Change in Total IBDQ Scores From Baseline to Weeks 8 [Time Frame: 8 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 [Time Frame: 2 Week]

Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 [Time Frame: 8 Week]

Cumulative Remission Rate at Week 4 [Time Frame: 4 Week]

Secondary ID(s)

D9423C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01514240