Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
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
1 other identifier
interventional
123
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2012
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedOctober 31, 2016
September 1, 2016
2.6 years
January 10, 2012
March 4, 2015
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission After 8-week of Treatment
For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.
8 Week
Secondary Outcomes (34)
Remission After 2-week of Treatment
2 Week
Remission After 4-week of Treatment
4 Week
Change in Observed CDAI Scores From Baseline to Weeks 2
2 Week
Change in Observed CDAI Scores From Baseline to Weeks 4
4 Week
Change in Observed CDAI Scores From Baseline to Weeks 8
8 Week
- +29 more secondary outcomes
Study Arms (2)
D9421-C
EXPERIMENTALD9421-C 9 mg once daily
Mesalazine
ACTIVE COMPARATORMesalazine 1 g three times a day
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Chikushino-shi, Japan
Research Site
Fukuoka, Japan
Research Site
Fukuyama-shi, Japan
Research Site
Hirosaki-shi, Japan
Research Site
Hiroshima, Japan
Research Site
Kagoshima, Japan
Research Site
Kitakyushu-shi, Japan
Research Site
Koshigaya-shi, Japan
Research Site
Kurume-shi, Japan
Research Site
Kyoto, Japan
Research Site
Nagakute-shi, Japan
Research Site
Nagoya, Japan
Research Site
Nishinomiya-shi, Japan
Research Site
Okayama, Japan
Research Site
Omura-shi, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Sakura, Japan
Research Site
Sapporo, Japan
Research Site
Sendai, Japan
Research Site
Shinjyuku-ku, Japan
Research Site
Suginami-ku, Japan
Research Site
Suita-shi, Japan
Research Site
Toyoake-shi, Japan
Research Site
Toyota-shi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masahiro Nii
- Organization
- Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
Study Officials
- PRINCIPAL INVESTIGATOR
Toshifumi Hibi, Professor, Chairman
Department of Internal Medicine, Keio University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 23, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 31, 2016
Results First Posted
October 31, 2016
Record last verified: 2016-09