A Double Blind Study for the Treatment of Acute Ulcerative Colitis
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Purpose
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Drug: Mesalamine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis. |
- Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3. [ Time Frame: week 3 and 6 ] [ Designated as safety issue: No ]
| Enrollment: | 772 |
| Study Start Date: | June 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Asacol 2.4 g/day (400 mg tablet)
|
Drug: Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks |
|
Active Comparator: 2
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
|
Drug: Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks |
Detailed Description:
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
- Female patients need to be postmenopausal or using adequate contraception.
Exclusion Criteria:
- Patients with isolated proctitis
- Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Contacts and Locations
Show 135 Study Locations| Study Director: | Piotr Krzeski, MD | Procter and Gamble |
More Information
Additional Information:
No publications provided
| Responsible Party: | Warner Chilcott |
| ClinicalTrials.gov Identifier: | NCT00350415 History of Changes |
| Obsolete Identifiers: | NCT00336440 |
| Other Study ID Numbers: | 2006444 |
| Study First Received: | July 6, 2006 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Warner Chilcott:
|
ulcerative colitis, inflammatory bowel disease |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013