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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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 Outcome(s)
Secondary ID(s)
14515A
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Procter and Gamble
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