Status:
COMPLETED
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Lead Sponsor:
Warner Chilcott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet for...
Eligibility Criteria
Inclusion
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
Exclusion
- Patients will be excluded from admission to the study if they have/are:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
- received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- received any other topical rectal therapy during the week prior to the Screening Visit;
- received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- if female, positive pregnancy test, or lactating.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00073021
Start Date
September 1 2000
End Date
September 1 2003
Last Update
June 29 2015
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
AGMG Clinical Research
Anaheim, California, United States, 92801
3
Research Site
Los Angeles, California, United States, 90067
4
Community Clinical Trials
Orange, California, United States, 38305