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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

NCT00573469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-07-12

Study results available
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Summary

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.

Conditions

Interventions

DRUG

D9421-C, 9mg

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

DRUG

D9421-C, 15mg

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Masataka Date, MD, PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00573469 on ClinicalTrials.gov