CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission

June 19, 2007 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission

This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective(s):

This study will compare the safety and efficacy of 25 mg per day (QD) and 50 mg QD of OPC-6535 to 800 mg twice a day (BID) of Asacol® in the maintenance of remission in subjects with ulcerative colitis.

Subject Population:

  • Subjects with ulcerative colitis currently in remission defined as rectal bleeding (RB) and flexible sigmoidoscopy (FS) scores of 0, on or off a stable dose of sulfasalazine or 5-ASA products for at least 6 weeks.
  • Subjects must have had the diagnosis of ulcerative colitis established by prior colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the Screening Period.
  • Subjects must have had treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
  • Subjects may not have used corticosteroids, topical agents (corticosteroid or 5-ASA enemas, suppositories, foams), azathioprine, 6-mercaptopurine, or methotrexate within 6 weeks of the Screening Period. Upon entry, sulfasalazine and 5-ASA containing products will be discontinued.

Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.

Study Type

Interventional

Enrollment (Anticipated)

1725

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • California
      • Los Angeles, California, United States, 90045
        • West Gastroenterology Medical Group
    • Florida
      • Hollywood, Florida, United States, 33021
        • Mark Lamet
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Palm Harbor, Florida, United States, 34684
        • Advanced Gastroenterology Associates
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic
    • Maryland
      • Annapolis, Maryland, United States, 21404
        • Digestive Disorders Associates
      • Chevy Cha, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group
    • Massachusetts
      • Braintree, Massachusetts, United States, 02184
        • Coastal Research Associates
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists, PA
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Atlantic Gastroenterology Associates, PA
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology
      • High Point, North Carolina, United States, 27262
        • Bethany Medical Center
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists, PA
    • Ohio
      • Dayton, Ohio, United States, 45440
        • GI & Liver Consultants
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Clinic of San Antonio
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Virginia
      • Richmond, Virginia, United States, 23149
        • McGuire DVAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects, 18 to 80 years of age, inclusive.
  • Subjects with a prior diagnosis of ulcerative colitis, established by colonoscopy.
  • Subjects currently in remission.
  • Subjects who have undergone treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
  • If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 6 weeks prior to the Screening Period. NOTE: During the study, use of these drugs will be discontinued.
  • Subjects having undergone colonoscopy with pan-colonic surveillance biopsies negative for dysplasia within 1 year of the Screening Visit if at increased risk of colorectal cancer (≥ 8 year history of ulcerative colitis).
  • Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening Period through 30 days (females) and 90 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study.

Exclusion Criteria:

  • Subjects who have active disease.
  • Subjects who have any other clinically significant disease(s) or condition/procedure(s).
  • Subjects who have had major gastrointestinal surgery including, but not limited to, a colostomy, an ileostomy or previous colonic surgery other than appendectomy.
  • Subjects who have used corticosteroids or topical agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 6 weeks of the Screening Period.
  • Female subjects who are pregnant or lactating.
  • Other exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

September 22, 2004

First Submitted That Met QC Criteria

September 27, 2004

First Posted (Estimate)

September 28, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 19, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197-02-220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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