Ulcerative Colitis
Conditions
Keywords
Mesalamine, Ulcerative Colitis
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.
Interventions
DRUGAsacol
Asacol is given once a day versus twice or three times a day
Sponsors
Procter and Gamble
Annette Langseder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Once Daily Dosing Works as Well a Multiple Dosing a Day. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Medication Compliance. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Asacol BID/TID Dosing | Total |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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
Time frame: 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
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asacol Once a Day Dosing | Improved Medication Compliance. | 0 Participants |
| Asacol BID/TID Dosing | Improved Medication Compliance. | 1 Participants |