Trial Outcomes & Findings for Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients (NCT NCT00349388)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

overall study

Results posted on

2019-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Asacol Once a Day Dosing Asacol total dose in mg/kg given once a day Asacol: Asacol is given once a day versus twice or three times a day	Asacol BID/TID Dosing Asacol total dose split BID or TID Asacol: Asacol is given once a day versus twice or three times a day
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asacol Once a Day Dosing Asacol total dose in mg/kg given once a day Asacol: Asacol is given once a day versus twice or three times a day	Asacol BID/TID Dosing n=1 Participants Asacol total dose split BID or TID Asacol: Asacol is given once a day versus twice or three times a day	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: overall study

Population: cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: overall study

Population: 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 a higher compliance than taking medication BID or TID. Study was terminated due to lack of enrollment.

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

Outcome measures

Outcome measures
Measure	Asacol Once a Day Dosing Asacol total dose in mg/kg given once a day Asacol: Asacol is given once a day versus twice or three times a day	Asacol BID/TID Dosing n=1 Participants Asacol total dose split BID or TID Asacol: Asacol is given once a day versus twice or three times a day
Improved Medication Compliance.	0 Participants	1 Participants

Adverse Events

Asacol Once a Day Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asacol BID/TID Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joel Rosh

Atlantic Health System

Phone: 973-971-5676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place