Phase 3
Completed N=268
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT00073021 ↗Enrolled (actual)
268
Serious AEs
1.9%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population — 59.2; 71.8 Percentage of Participants — p=0.0357
Summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population |
59.2; 71.8 | 0.0357 sig |
| SECONDARY Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population |
-3.2; -3.7 | 0.1594 |
| SECONDARY Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population |
59.8; 63.6 | 0.5774 |
| SECONDARY Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population |
69.0; 75.2 | 0.2991 |
| SECONDARY Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 |
71.3; 74.0 | 0.6543 |
| SECONDARY Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 |
77.5; 78.5 | 0.8542 |
| SECONDARY Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 |
70.5; 69.6 | 0.8859 |
| SECONDARY Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 |
73.5; 83.2 | 0.0758 |
| SECONDARY Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients |
30.4; 29.8 | 0.8308 |
| SECONDARY Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients |
43.1; 40.4 | 0.5340 |
| SECONDARY Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients |
60.0; 71.1 | 0.0966 |
| SECONDARY Percentage of Treatment Success Patients at Week 3, ITT Population |
51.5; 61.3 | 0.1173 |
Eligibility Criteria
Inclusion Criteria
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
Exclusion Criteria
Patients will be excluded from admission to the study if they have/are:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
- received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- received any other topical rectal therapy during the week prior to the Screening Visit;
- received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- if female, positive pregnancy test, or lactating.
Data sourced from ClinicalTrials.gov (NCT00073021). 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.