A Comparison of Once a Day Dose Compared to 2 Doses/Day

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Detailed Description
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Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a real life practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

Official Title
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A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Mesalamine Once-Daily
* Drug: Mesalamine Twice-Daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry At least one flare in the past 18 months Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months) Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception Exclusion Criteria: History of or current renal disease History of hepatic disease History of allergy or hypersensitivity to salicylates, aminosalicylates Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesalamine (Asacol) Once-Daily<br>an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day) | Drug: Mesalamine Once-Daily<br>* Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks<br>* Other names: Asacol QD;|
| Active Comparator: Mesalamine (Asacol) Twice-Daily<br>an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day) | Drug: Mesalamine Twice-Daily<br>* Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks<br>* Other names: Asacol BID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) | Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Remaining in Remission at Month 3, ITT Population | Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). | 3 months | 
| Percentage of Patients Remaining in Remission at Month 12, ITT Population | Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). | 12 months | 
| Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). | 6 months | 
| Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 | MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45. | 6 months | 
| Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6 | Is your ulcerative colitis in remission (not active)? Y/N | 6 months |