Asacol Dosing Study for Active Ulcerative Colitis - Full Text View

Purpose

We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on its ability to induce remission in patients with mild to moderately active ulcerative colitis. We hypothesize that both regimens will have the same efficacy and no difference in side effects.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Asacol (mesalamine)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Open Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative Colitis

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine Mesalamine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Proportion of patients in each arm that have presence of clinical remission by week 12, as defined by UCAI score of less than or equal to 4. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients in each arm who respond to therapy as measured by a reduction in UCAI score of greater than or equal to 4. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Proportion of patients in each arm who have improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to clinical response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Self reported patient satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient compliance based on pill count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	June 2003
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Asacol 6 tablets BID (4.8 grams/day)	Drug: Asacol (mesalamine) Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks. Other Name: Mesalamine
Active Comparator: 2 Asacol 4 tablets TID (4.8 grams/day)	Drug: Asacol (mesalamine) Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks. Other Name: Mesalamine

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide consent
Age older than 18 years and younger than 80 years
Confirmed diagnosis of ulcerative colitis by endoscopic or radiologic evaluation at least 4 weeks prior to randomization
Active ulcerative colitis at time of screening (UCAI > 4 <12)
Receiving stable doses of medications at least 4 weeks prior to receiving the first dose of study drug
Agree to use of an adequate form of contraception throughout the study period for sexually active males and females of child-bearing potential
Able to comply with protocol requirements
Subjects may not be on any form of corticosteroids, immunosuppressives or anti-tumor necrosis factor (TNF) therapy

Exclusion Criteria:

Critically ill
Risk factors for toxicity to Asacol, including pre-existing hepatic disease (biopsy-proven cirrhosis, chronic active hepatitis, or serum aspartate aminotransferase, bilirubin, or alkaline phosphatase concentrations at least twice the upper limit of normal except for patients with the diagnosis of primary sclerosing cholangitis, a liver disease which occurs in patients with ulcerative colitis), renal dysfunction (serum creatinine concentration greater than 1.7 mg per deciliter [150mmol per liter]). Patients with primary sclerosing cholangitis (PSC), a liver disease that is often associated with ulcerative colitis, will be allowed to participate in the study if their liver function tests have been stable for at least 4 weeks. Previous studies have not shown any detrimental effects of Asacol on PSC.
Systemic infections
Pregnancy or a desire to become pregnant
High alcohol consumption (more than seven drinks per week)
Known hypersensitivity to Asacol
Estimated survival of less than one year
Unwilling to comply with the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194818

Locations

United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

Procter and Gamble

Investigators

Principal Investigator:

Scott D Lee, MD

University of Washington

More Information

No publications provided

Responsible Party:	Scott D. Lee, MD, University of Washington
ClinicalTrials.gov Identifier:	NCT00194818 History of Changes
Other Study ID Numbers:	04-1694-A 01
Study First Received:	September 15, 2005
Last Updated:	February 13, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013