A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

NCT00317356 | Terminated Phase 2 Results

• 2 other identifiers: 197-05-002JapicCTI-060216
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Conditions

Colitis, Ulcerative

Keywords

OPC-6535; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration

  Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline

  Weeks 4 and 8

Secondary Outcomes (7)

• Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration

  Weeks 4 and 8

• Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration

  Baseline, Weeks 4 and 8

• Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration

  Baseline, Weeks 4 and 8

• Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration

  Baseline, Weeks 2, 4 and 8

• Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration

  Baseline and Week 8

Interventions

OPC-6535(Tetomilast) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with active ulcerative colitis
• Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
• Either inpatient or outpatient

You may not qualify if:

• Patients who have a history of intestinal resection (other than appendiceal resection)
• Patients who have a complication of malignant tumor
• Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Touhoku Region, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

tetomilast

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  Division of New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 24, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 30, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-04

Locations

JP (8)