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

January 9, 2019 updated by: Annette Langseder

A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital/Goyerb Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asacol once a day dosing
Asacol total dose in mg/kg given once a day
Drug: Asacol
Asacol is given once a day versus twice or three times a day
Other Names:
  • Mesallamine
Active Comparator: Asacol BID/TID dosing
Asacol total dose split BID or TID
Drug: Asacol
Asacol is given once a day versus twice or three times a day
Other Names:
  • Mesallamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Once Daily Dosing Works as Well a Multiple Dosing a Day.
Time Frame: overall study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Medication Compliance.
Time Frame: overall study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annette Langseder

Collaborators

Procter and Gamble

Investigators

  • Principal Investigator: Joel Rosh, MD, Atlantic Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 7, 2006

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R05-11-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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