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Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

NCT01130844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Conditions

Interventions

DRUG

MMX Mesalamine

30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

DRUG

MMX Mesalamine

60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

DRUG

MMX Mesalamine

100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-08
Primary Completion
2013-06-27
Completion
2013-06-27

Countries

  • United States
  • Australia
  • Poland
  • Slovakia
  • United Kingdom

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 NCT01130844 on ClinicalTrials.gov