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A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

NCT00254618 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-04-17

No results posted yet for this study

Summary

The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.

Conditions

Interventions

DRUG

mesalamine

oral tablet, 30 mg mesalamine/day for 28 days

DRUG

mesalamine

oral tablet, 60 mg mesalamine/day for 28 days

DRUG

mesalamine

oral tablet, 90 mg mesalamine/day for 28 days

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • William Aronstein, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00254618 on ClinicalTrials.gov