Study Stopped
none enrolled in second arm, therfore no analysis
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedJanuary 29, 2019
January 1, 2019
4.5 years
July 5, 2006
July 24, 2014
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Improved Medication Compliance.
overall study
Study Arms (2)
Asacol once a day dosing
EXPERIMENTALAsacol total dose in mg/kg given once a day
Asacol BID/TID dosing
ACTIVE COMPARATORAsacol total dose split BID or TID
Interventions
Asacol is given once a day versus twice or three times a day
Eligibility Criteria
You may qualify if:
- Ages 6 to 18 years,
- Must be able to swallow tablets, and
- Biopsy proven ulcerative colitis
You may not qualify if:
- Allergy or hypersensitivity to Mesalamine or other salicylates
- Use of rectal medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Annette Langsederlead
- Procter and Gamblecollaborator
Study Sites (1)
Morristown Memorial Hospital/Goyerb Children's Hospital
Morristown, New Jersey, 07962, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No subjects were analysed due to lack of enrollment. No subject was enrolled into the once a day dosing arm to answer our primary or secondary outcomes.
Results Point of Contact
- Title
- Dr. Joel Rosh
- Organization
- Atlantic Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Rosh, MD
Atlantic Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Joel Rosh, MD
Study Record Dates
First Submitted
July 5, 2006
First Posted
July 7, 2006
Study Start
July 1, 2006
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 29, 2019
Results First Posted
August 15, 2014
Record last verified: 2019-01