Study identifier:D9423C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Crohn's disease
Phase 3
No
D9421-C capsule 3 mg, Mesalazine tablets
All
123
Interventional
15 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2014 by AstraZeneca
AstraZeneca
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The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.
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
Location
Location
Sapporo-shi, Japan
Location
Sendai-shi, Japan
Location
Shinjyuku-ku, Japan
Location
Nagoya-shi, Japan
Location
Suita-shi, Japan
Location
Kurume-shi, Japan
Location
Osaka, Japan
Location
Nishinomiya-shi, Japan
Arms | Assigned Interventions |
---|---|
Experimental: D9421-C D9421-C 9 mg once daily | Drug: D9421-C capsule 3 mg Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. |
Active Comparator: Mesalazine Mesalazine 1 g three times a day | Drug: Mesalazine tablets Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. |
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