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

Crohn's Disease Clinical Trial

Official title:

A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989573
• Other study ID #: 197-08-001
• Secondary ID: JapicCTI090915
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Placebo
oral administration of placebo once-daily for 8 weeks
• OPC-6535
oral administration of OPC-6535 25 mg once-daily for 8 weeks
• OPC-6535
oral administration of OPC-6535 50 mg once-daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration	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)	Week 8
Secondary	Clinical Improvement Rate After 4 Weeks of IMP Administration	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)	Week 4
Secondary	Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration	Definition of remission: Total CDAI score improved to below 150	Weeks 4 and 8
Secondary	Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration		Baseline, Weeks 4 and 8