Ulcerative Colitis Clinical Trial
Official title:
A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis
NCT number | NCT00349388 |
Other study ID # | R05-11-010 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2006 |
Est. completion date | January 2011 |
Verified date | January 2019 |
Source | Atlantic Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Status | Terminated |
Enrollment | 1 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Ages 6 to 18 years, - Must be able to swallow tablets, and - Biopsy proven ulcerative colitis Exclusion Criteria: - Allergy or hypersensitivity to Mesalamine or other salicylates - Use of rectal medications |
Country | Name | City | State |
---|---|---|---|
United States | Morristown Memorial Hospital/Goyerb Children's Hospital | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Annette Langseder | Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Once Daily Dosing Works as Well a Multiple Dosing a Day. | subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported | overall study | |
Secondary | Improved Medication Compliance. | Not applicable : unable to measure secondary outcome because no one was enrolled in once a day dose arm. Therefore, no comparisons can be made to see if once a day dosing would have higher compliance than taking medication BID or TID | overall study |
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