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Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

NCT ID: NCT00573469

Last Updated: 2012-07-12

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

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.

Detailed Description

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Conditions

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Crohn's Disease

Keywords

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gastrointestinal GI Crohn's disease Japan Japanese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

D9421-C 9 mg

Group Type ACTIVE_COMPARATOR

D9421-C, 9mg

Intervention Type DRUG

D9421-C 9 mg was given once daily for 8 weeks.

2

D9421-C 15 mg

Group Type ACTIVE_COMPARATOR

D9421-C, 15mg

Intervention Type DRUG

D9421-C 15 mg was given once daily for 8 weeks.

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

D9421-C matching placebo was given once daily for 8 weeks.

Interventions

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D9421-C, 9mg

D9421-C 9 mg was given once daily for 8 weeks.

Intervention Type DRUG

D9421-C, 15mg

D9421-C 15 mg was given once daily for 8 weeks.

Intervention Type DRUG

Placebo

D9421-C matching placebo was given once daily for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female or male aged ≥ 18 and ≤ 65 years
* Diagnosis of Crohn's Disease

Exclusion Criteria

* Having ileostomy or pouch and/or colostomy
* Having previous gastric surgery
* Having a known or suspected systemic infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Masataka Date, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Sakura, Chiba, Japan

Site Status

Research Site

Chikushino-shi, Fukuoka, Japan

Site Status

Research Site

Fukuoka, Fukuoka, Japan

Site Status

Research Site

Kurume, Fukuoka, Japan

Site Status

Research Site

Hashima-gun, Gifu, Japan

Site Status

Research Site

Fukuyama, Hiroshima, Japan

Site Status

Research Site

Hiroshima, Hiroshima, Japan

Site Status

Research Site

Asahikawa, Hokkaido, Japan

Site Status

Research Site

Sapporo, Hokkaido, Japan

Site Status

Research Site

Kobe, Hyōgo, Japan

Site Status

Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Ōita, Oita Prefecture, Japan

Site Status

Research Site

Kurashiki, Okayama-ken, Japan

Site Status

Research Site

Osaka, Osaka, Japan

Site Status

Research Site

Suita, Osaka, Japan

Site Status

Research Site

Tokorozawa, Saitama, Japan

Site Status

Research Site

Shinjuku-ku, Tokyo, Japan

Site Status

Research Site

Toyama, Toyama, Japan

Site Status

Research Site

Itami, , Japan

Site Status

Research Site

Nishinomiya, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Suzuki Y, Motoya S, Takazoe M, Kosaka T, Date M, Nii M, Hibi T. Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study. J Crohns Colitis. 2013 Apr;7(3):239-47. doi: 10.1016/j.crohns.2012.06.006. Epub 2012 Jul 4.

Reference Type DERIVED
PMID: 22766525 (View on PubMed)

Other Identifiers

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D9421C00002

Identifier Type: -

Identifier Source: org_study_id