Phase 3
Completed N=301
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Source: ClinicalTrials.gov NCT00577473 ↗Enrolled (actual)
301
Serious AEs
1.3%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Patients Classified as Treatment Success at Week 6, ITT Population — 51.3; 55.9 Percentage of Participants — p=0.4411
Summary
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Classified as Treatment Success at Week 6, ITT Population |
51.3; 55.9 | 0.4411 |
| SECONDARY Percentage of Patients Classified as Treatment Success at Week 3, ITT Population |
42.0; 38.7 | 0.5677 |
| SECONDARY Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients |
49.3; 44.8 | 0.4730 |
| SECONDARY Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients |
61.4; 64.8 | 0.5761 |
| SECONDARY Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) |
46.7; 54.3 | 0.2150 |
| SECONDARY Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) |
63.2; 66.7 | 0.5569 |
| SECONDARY Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) |
48.1; 59.1 | 0.0769 |
| SECONDARY Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) |
60.2; 71.5 | 0.0551 |
| SECONDARY Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) |
42.2; 49.6 | 0.2306 |
| SECONDARY Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) |
54.1; 60.7 | 0.2931 |
| SECONDARY Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) |
51.5; 52.0 | 0.9349 |
| SECONDARY Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) |
66.7; 73.2 | 0.2583 |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of ulcerative colitis
Exclusion Criteria
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection
Data sourced from ClinicalTrials.gov (NCT00577473). 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.