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

Annette Langseder

Status: Terminated

Conditions: Ulcerative Colitis

Treatments: Drug: Asacol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00349388

R05-11-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Asacol once a day dosing

Experimental group

Description:

Asacol total dose in mg/kg given once a day

Treatment:

Drug: Asacol

Asacol BID/TID dosing

Active Comparator group

Description:

Asacol total dose split BID or TID

Treatment:

Drug: Asacol