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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00349388
Other study ID # R05-11-010
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2006
Est. completion date January 2011

Study information

Verified date January 2019
Source Atlantic Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Morristown Memorial Hospital/Goyerb Children's Hospital Morristown New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Annette Langseder Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 overall study
Secondary 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 overall study
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