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

NCT00349388 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-01-29

Study results available
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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.

Conditions

Interventions

DRUG

Asacol

Asacol is given once a day versus twice or three times a day

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY
  • Annette Langseder

    lead OTHER

Principal Investigators

  • Joel Rosh, MD · Atlantic Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349388 on ClinicalTrials.gov