Status:
TERMINATED
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
Lead Sponsor:
Annette Langseder
Collaborating Sponsors:
Procter and Gamble
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
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 chil...
Detailed Description
Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Eligibility Criteria
Inclusion
- Ages 6 to 18 years,
- Must be able to swallow tablets, and
- Biopsy proven ulcerative colitis
Exclusion
- Allergy or hypersensitivity to Mesalamine or other salicylates
- Use of rectal medications
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00349388
Start Date
July 1 2006
End Date
January 1 2011
Last Update
January 29 2019
Active Locations (1)
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1
Morristown Memorial Hospital/Goyerb Children's Hospital
Morristown, New Jersey, United States, 07962