A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Asacol 800 mg (mesalamine)
+ Asacol 400 mg (mesalamine)
Colitis+7
+ Colitis, Ulcerative
+ Colonic Diseases
Treatment Study
Summary
Study start date: September 1, 2000
Actual date on which the first participant was enrolled.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 formulation will be evaluated at one of the two doses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.386 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 57 locations
AGMG Clinical Research
Anaheim, United StatesResearch Site
Los Angeles, United StatesCommunity Clinical Trials
Orange, United States