Clinical trial NCT00092508: CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis Remission
ulcerative
colitis
remission
relapse
Asacol®
maintain
maintenance
flare
rectal
bleeding
bowel
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1725
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

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