Phase 3
Completed N=1,027
A Comparison of Once a Day Dose Compared to 2 Doses/Day
Source: ClinicalTrials.gov NCT00505778 ↗Enrolled (actual)
1,027
Serious AEs
2.6%
Results posted
May 2011
Primary outcomePrimary: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) — 90.5; 91.8 Percentage of Participants — p=0.5016
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) |
90.5; 91.8 | 0.5016 |
| SECONDARY Percentage of Patients Remaining in Remission at Month 3, ITT Population |
94.8; 95.6 | 0.5426 |
| SECONDARY Percentage of Patients Remaining in Remission at Month 12, ITT Population |
85.4; 85.4 | 0.9770 |
| SECONDARY Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population |
45; 39 | 0.4726 |
| SECONDARY Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 |
42.3; 41.8 | 0.1753 |
| SECONDARY Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6 |
83.1; 86.6 | 0.1557 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00505778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.