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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092508
• Other study ID #: 197-02-220
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: June 19, 2007
• Start date: May 2004
• Est. completion date: May 2007

Study information

• Verified date: June 2007
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1725
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• OPC-6535

• Asacol®

Locations

Country	Name	City	State
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Coastal Research Associates	Braintree	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Charlotte Gastroenterology & Hepatology	Charlotte	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group	Chevy Cha	Maryland
United States	GI & Liver Consultants	Dayton	Ohio
United States	Atlantic Gastroenterology Associates, PA	Egg Harbor Township	New Jersey
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Bethany Medical Center	High Point	North Carolina
United States	Mark Lamet	Hollywood	Florida
United States	Clinical Research Associates	Huntsville	Alabama
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	West Gastroenterology Medical Group	Los Angeles	California
United States	Center for Digestive and Liver Diseases	Mexico	Missouri
United States	Advanced Research Institute	Ogden	Utah
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Advanced Gastroenterology Associates	Palm Harbor	Florida
United States	McGuire DVAMC	Richmond	Virginia
United States	Gastroenterology Clinic of San Antonio	San Antonio	Texas
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Digestive Health Specialists, PA	Tupelo	Mississippi
United States	Hanover Medical Specialists, PA	Wilmington	North Carolina
United States	Florida Medical Clinic	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States,