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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebo; Drug: OPC-6535; Drug: OPC-6535

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu Region, Japan
  • Chugoku Region, Japan
  • Hokkaido Region, Japan
  • Kanto Region, Japan
  • Kinki Region, Japan
  • Kyushu Region, Japan
  • Tohoku Region, Japan
• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gyronggi-do, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; oral administration of placebo once-daily for 8weeks	Drug: Placebo; oral administration of placebo once-daily for 8 weeks
EXPERIMENTAL: OPC-6535 25 mg; oral administration of OPC-6535 25 mg once-daily for 8 weeks	Drug: OPC-6535; oral administration of OPC-6535 25 mg once-daily for 8 weeks; Drug: OPC-6535; oral administration of OPC-6535 50 mg once-daily for 8 weeks
EXPERIMENTAL: OPC-6535 50 mg; oral administration of OPC-6535 50mg once-daily for 8 weeks	Drug: OPC-6535; oral administration of OPC-6535 25 mg once-daily for 8 weeks; Drug: OPC-6535; oral administration of OPC-6535 50 mg once-daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration		Baseline, Weeks 4 and 8

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Katsuhisa Saito, OPCJ

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: October 2, 2009
• First Submitted That Met QC Criteria: October 2, 2009
• First Posted (ESTIMATE): October 5, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 197-08-001; JapicCTI090915