A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: OPC-6535; Drug: Placebo

• Registration Number: NCT00989573
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid \[5-ASA\] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2021-03
• Results First Submitted: 2021-03-11
• Results First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Results First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• Primary lesion in either small intestine or large intestine
• C-reactive protein (CRP) level above the upper limit of the normal range
• Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
• Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria

• Patients with an uncontrolled external fistula (including anal fistula)
• Patients with a history of total proctocolectomy or subtotal colectomy
• Patients with short bowel syndrome
• Patients with an artificial anus
• Patients with serious infectious disease (intra-abdominal abscess, etc)
• Patients with malignant tumor
• Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC-6535 50 mg	OPC-6535	oral administration of OPC-6535 50mg once-daily for 8 weeks
Placebo	Placebo	oral administration of placebo once-daily for 8weeks
OPC-6535 25 mg	OPC-6535	oral administration of OPC-6535 25 mg once-daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration	Week 8	Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: remission, CDAI \> 450: severe disease)

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration	Baseline, Weeks 4 and 8
Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration	Weeks 4 and 8	Definition of remission: Total CDAI score improved to below 150
Clinical Improvement Rate After 4 Weeks of IMP Administration	Week 4	Definition of clinical improvement: CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: remission, CDAI \> 450: severe disease)