An interventional study of Asacol in Ulcerative Colitis, sponsored by Annette Langseder. Terminated at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Annette Langseder · Not applicable, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →This is the only study on the registry with Annette Langseder as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Asacol total dose in mg/kg given once a day
Drug: Asacol
Asacol total dose split BID or TID
Drug: Asacol
Asacol is given once a day versus twice or three times a day
Also known as: Mesallamine
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
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
| Milestone | Asacol Once a Day Dosing | Asacol BID/TID Dosing |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
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
| Participants | Asacol Once a Day Dosing | Asacol BID/TID Dosing |
|---|---|---|
| Improved Medication Compliance. | 0 | 1 |
Collected over 180 days total. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asacol Once a Day Dosing | — | — | — |
| Asacol BID/TID Dosing | — | 0/1 (0%) | 0/1 (0%) |
No patients enrolled into intervention arm due to lack of enrollment.Only 1 subject was enrolled in Control arm. Therefore no data can be compared for study outcome
| Age, Categorical(Participants) | Asacol Once a Day Dosing | Asacol BID/TID Dosing | Total |
|---|---|---|---|
| <=18 years | — | 1 | 1 |
| Between 18 and 65 years | — | 0 | 0 |
| >=65 years | — | 0 | 0 |
| Sex: Female, Male(Participants) | Asacol Once a Day Dosing | Asacol BID/TID Dosing | Total |
|---|---|---|---|
| Female | — | 0 | 0 |
| Male | — | 1 | 1 |
| Region of Enrollment(participants) | Asacol Once a Day Dosing | Asacol BID/TID Dosing | Total |
|---|---|---|---|
| United States | — | 1 | 1 |
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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