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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Asacol

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Mesalamine, Ulcerative Colitis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Morristown Memorial Hospital/Goyerb Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asacol once a day dosing

Asacol BID/TID dosing

Arm Description

Asacol total dose in mg/kg given once a day

Asacol total dose split BID or TID

Outcomes

Primary Outcome Measures

Once Daily Dosing Works as Well a Multiple Dosing a Day.

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

Secondary Outcome Measures

Improved Medication Compliance.

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

Full Information

NCT ID

NCT00349388

First Posted

July 5, 2006

Last Updated

January 9, 2019

Sponsor

Annette Langseder

Collaborators

Procter and Gamble

1. Study Identification

Unique Protocol Identification Number

NCT00349388

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

none enrolled in second arm, therfore no analysis

Study Start Date

July 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Annette Langseder

Collaborators

Procter and Gamble

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Mesalamine, Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Asacol once a day dosing

Arm Type

Experimental

Arm Description

Asacol total dose in mg/kg given once a day

Arm Title

Asacol BID/TID dosing

Arm Type

Active Comparator

Arm Description

Asacol total dose split BID or TID

Intervention Type

Drug

Intervention Name(s)

Asacol

Other Intervention Name(s)

Mesallamine

Intervention Description

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

Primary Outcome Measure Information:

Title

Once Daily Dosing Works as Well a Multiple Dosing a Day.

Description

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

Time Frame

overall study

Secondary Outcome Measure Information:

Title

Improved Medication Compliance.

Description

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

Time Frame

overall study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Rosh, MD

Organizational Affiliation

Atlantic Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Morristown Memorial Hospital/Goyerb Children's Hospital

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Ulcerative Colitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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