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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00343850
• Date of registration: 21/06/2006
• Primary sponsor: University of Chicago
• Public title: Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis
• Scientific title: Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot Trial
• Date of first enrolment: September 2006
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00343850
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Sunanda Kane, MD
• Affiliation: University of Chicago

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Asacol (mesalamine)

Primary Outcome(s)

12-month study period

calculation of medication consumption rates at months 3, 6, 9 and 12

disease relapse

Secondary ID(s)

14515A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Procter and Gamble