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

NCT ID: NCT01514240

Last Updated: 2016-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Crohn's Disease

Keywords

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mild to moderate active Crohn's disease affecting ileum ileocecal region ascending colon score of 180-400 on the CDAI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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D9421-C

D9421-C 9 mg once daily

Group Type EXPERIMENTAL

D9421-C capsule 3 mg

Intervention Type DRUG

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.

Mesalazine

Mesalazine 1 g three times a day

Group Type ACTIVE_COMPARATOR

Mesalazine tablets

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshifumi Hibi, Professor, Chairman

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Keio University School of Medicine

Locations

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Research Site

Chikushino-shi, , Japan

Site Status

Research Site

Fukuoka, , Japan

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Fukuyama-shi, , Japan

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Hirosaki-shi, , Japan

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Hiroshima, , Japan

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Kagoshima, , Japan

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Kitakyushu-shi, , Japan

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Koshigaya-shi, , Japan

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Kurume-shi, , Japan

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Kyoto, , Japan

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Nagakute-shi, , Japan

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Nagoya, , Japan

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Nishinomiya-shi, , Japan

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Okayama, , Japan

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Omura-shi, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Sakura, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Shinjyuku-ku, , Japan

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Suginami-ku, , Japan

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Suita-shi, , Japan

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Toyoake-shi, , Japan

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Research Site

Toyota-shi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D9423C00001

Identifier Type: -

Identifier Source: org_study_id