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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mesalamine Once-Daily; Drug: Mesalamine Twice-Daily

• Registration Number: NCT00505778
• Lead Sponsor: Warner Chilcott

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2011-04-18
• Results First Submitted QC: 2011-04-18
• Results First Posted: 2011-05-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesalamine (Asacol) Once-Daily	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine (Asacol) Twice-Daily	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Remaining in Remission at Month 3, ITT Population	3 months	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).
Percentage of Patients Remaining in Remission at Month 12, ITT Population	12 months	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).
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population	6 months	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).
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6	6 months	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.
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6	6 months	Is your ulcerative colitis in remission (not active)? Y/N

Trial Locations

Locations (2)

Research Site; 🇺🇸 Hackensack, New Jersey, United States

Research Facility; 🇵🇷 San Juan, Puerto Rico