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| Sponsor: | Procter and Gamble |
|---|---|
| Information provided by: | Procter and Gamble |
| ClinicalTrials.gov Identifier: | NCT00554099 |
Purpose
The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Diverticulitis |
Drug: mesalamine Other: placebo Drug: Mesalamine and Align |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-Free Observation Period |
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
|
Drug: mesalamine
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
|
|
2: Active Comparator
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.
|
Drug: Mesalamine and Align
6 tablets once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.
|
|
3: Placebo Comparator
6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.
|
Other: placebo
6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.
|
This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.
Eligibility| Ages Eligible for Study: | 49 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 30 Study Locations| Study Director: | Ana Balske, MD, PhD | Procter and Gamble |
More Information
| Responsible Party: | Procter and Gamble Pharmaceuticals ( Simon Magowan, MD ) |
| Study ID Numbers: | 2007020 |
| Study First Received: | November 2, 2007 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00554099 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Mesalamine Physiological Effects of Drugs Pharmacologic Actions Diverticulitis Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |