Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis

This study has been terminated.

( Enrollment completed )

First Received on June 21, 2006. Last Updated on March 16, 2007 History of Changes

Sponsor:	University of Chicago
Collaborator:	Procter and Gamble
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00343850

Purpose

The purpose of this study is to determine if taking Asacol once a day is as effective as taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is experimental, and has not been approved by the FDA. Dosing as three times daily is FDA approved.

This research is being done because the researchers want to learn what the best methods are for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to subjects in continuing to take a medication to control their ulcerative colitis.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

calculation of medication consumption rates at months 3, 6, 9 and 12
disease relapse
12-month study period

Estimated Enrollment:	30
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2012

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients over the age of 18 followed at the University of Chicago Outpatient Gastroenterology Clinic will be eligible. Patients must have documentation of ulcerative colitis by standard criteria, and be in remission for at least 4 months prior to study entry. Remission for this study will be defined clinically, as the absence of all of the following: blood in the stools, urgency, or cramping. Patients must be taking a regimen of Asacol (Asacol, Procter and Gamble, Cincinnati Ohio) for maintenance of quiescent disease

Exclusion Criteria:

Exclusion criteria include documented disease activity in the past four months, hospitalization or steroid use for disease activity in the previous 4 months, or the use of other immunomodulators to induce remission. Patients with a history of other diarrheal illnesses such as diarrhea-predominant Irritable Bowel Syndrome, C difficile colitis, use of known diarrheal drugs will also be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343850

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Procter and Gamble

Investigators

Principal Investigator:

Sunanda Kane, MD

University of Chicago

More Information

Publications:

Silverstein MD, Lashner BA, Hanauer SB. Cigarette smoking and ulcerative colitis: a case-control study. Mayo Clin Proc. 1994 May;69(5):425-9.

Fraga XF, Vergara M, Medina C, Casellas F, Bermejo B, Malagelada JR. Effects of smoking on the presentation and clinical course of inflammatory bowel disease. Eur J Gastroenterol Hepatol. 1997 Jul;9(7):683-7.

ClinicalTrials.gov Identifier:	NCT00343850 History of Changes
Other Study ID Numbers:	14515A
Study First Received:	June 21, 2006
Last Updated:	March 16, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

idiopathic chronic inflammatory disease of large intestine
ulcerative colitis
inactive ulcerative colitis
chronic disease of large intestine

medication adherence
Asacol
mesalamine

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 February 12, 2012