Not provided
Not provided
Not provided
Not provided
Not provided
none enrolled in second arm, therfore no analysis
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asacol once a day dosing | Experimental | Asacol total dose in mg/kg given once a day |
|
| Asacol BID/TID dosing | Active Comparator | Asacol total dose split BID or TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asacol | Drug | Asacol is given once a day versus twice or three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel Rosh, MD | Atlantic Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morristown Memorial Hospital/Goyerb Children's Hospital | Morristown | New Jersey | 07962 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment | Posted | overall study |
|
180 days total
No subjects were enrolled in the once daily dosing arm. Therefore, no subject was at risk for Serious Adverse Events or non Serious Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joel Rosh | Atlantic Health System | 973-971-5676 | joel.rosh@atlantichealth.org |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | 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. | Posted | Count of Participants | Participants | overall study |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |