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

This study has been completed.
Procter and Gamble
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
First received: June 21, 2006
Last updated: January 9, 2013
Last verified: January 2013

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 3

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:

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

Enrollment: 30
Study Start Date: September 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description


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

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

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Procter and Gamble
Principal Investigator: Sunanda Kane, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00343850     History of Changes
Other Study ID Numbers: 14515A 
Study First Received: June 21, 2006
Last Updated: January 9, 2013
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

Additional relevant MeSH terms:
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016