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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: D9421-C capsule 3 mg; Drug: Mesalazine tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514240

D9423C00001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 123 patients

Sex: All

Ages: 15 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups

D9421-C

Experimental group

Description:

D9421-C 9 mg once daily

Treatment:

Drug: D9421-C capsule 3 mg

Mesalazine

Active Comparator group

Description:

Mesalazine 1 g three times a day

Treatment:

Drug: Mesalazine tablets