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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: D9421-C, 15mg; Drug: D9421-C, 9mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00573469

D9421C00002

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

D9421-C 9 mg

Treatment:

Drug: D9421-C, 9mg

2

Active Comparator group

Description:

D9421-C 15 mg

Treatment:

Drug: D9421-C, 15mg

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo