Phase III study of D9421-C 9 mg in patients with active Crohn's Disease in Japan
Study identifier:D9423C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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
Medical condition
Crohn's disease
Phase
Phase 3
Healthy volunteers
No
Study drug
D9421-C capsule 3 mg, Mesalazine tablets
Sex
All
Actual Enrollment
123
Study type
Interventional
Age
15 Years - 150 Years
Date
Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Sept 2014
Study Completion Date: 01 Sept 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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. |
Contacts
Investigators
Principal Investigator
Toshifumi Hibi
Department of Internal Medicine, Keio University School of Medicine
