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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00349388
• Other study ID #: R05-11-010
• Status: Terminated
• Phase: N/A
• Start date: July 2006
• Est. completion date: January 2011

Study information

• Verified date: January 2019
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Asacol
Asacol is given once a day versus twice or three times a day

Locations

Country	Name	City	State
United States	Morristown Memorial Hospital/Goyerb Children's Hospital	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Annette Langseder	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

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