Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients

Not Applicable

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: Asacol

• Registration Number: NCT00349388
• Lead Sponsor: Annette Langseder

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 children and adolescence.

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2014-07-24
• Results First Submitted QC: 2014-08-13
• Results First Posted: 2014-08-15
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asacol once a day dosing	Asacol	Asacol total dose in mg/kg given once a day
Asacol BID/TID dosing	Asacol	Asacol total dose split BID or TID

Primary Outcome Measures

Name	Time	Method
Once Daily Dosing Works as Well a Multiple Dosing a Day.	overall study	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

Secondary Outcome Measures

Name	Time	Method
Improved Medication Compliance.	overall study	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

Trial Locations

Locations (1)

Morristown Memorial Hospital/Goyerb Children's Hospital; 🇺🇸 Morristown, New Jersey, United States