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Clinical Trial Details
| A Multicenter, Double-Blind, Controlled, Randomized, Parallel Group Comparison Phase IIIA Treatment Investigation on the Efficacy and Safety of Max-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis |
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| Category: Ulcerative Colitis, Mild to moderate |
| Date Posted: 2010-01-05 |
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Principle Investigator: |
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Dr. Daniel Geenen
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Study Coordinator: |
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Brenda Giesen
414-908-6630
brendagi@wigia.com
Fax: 414-908-6623
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Site Address: |
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Wisconsin Center for Advanced Research
A Division of GI Associates, LLC
2801 W. Kinnickinnic River Pkwy., Suite 1030
Milwaukee, Wisconsin 53215 United States
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The purpose of this research study is to evaluate the efficacy and safety of new investigational mesalamine suppositories as compared to placebo in adults with mild to moderate ulcerative proctitis (disease located in the rectum). Patients found to be eligible will be randomized to receive either a new formulation of mesalamine (5-ASA) 1 g suppositories, Canasa 1 g suppositories, or Placebo suppositories once daily at bedtime for 6 weeks. Regardless of the study groups, all patients will be evaluated through phone calls at Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6 and 14. A total of 5 clinical visits are planned over a period of 16 weeks. Study-specific procedures include but are not limited to the following: flexible proctosigmoidoscopy (visualization of the interior of the rectum) with or without tissue sampling; disease activity assessment; health-related quality of life assessment; compliance to treatment check and safety evaluations. In research studies, the most frequent side effects occurring in adult patients treated with mesalamine rectal suppositories are: inflammation of the colon; rectal pain; fever; dizziness; acne; rash; abdominal pain; diarrhea; gas nausea; and headache. In addition, hypersensitivity reaction can occur in patients with allergy to mesalamine or sulfasalazine (a marketed product containing 5- ASA). For further information on potential side effects with Canasa suppositories, please refer to the US Prescribing Information. The study doctor will discuss the study with you in more detail and provide you with a full description of potential side effects or risks. Any questions or concerns you may have can be addressed with the study doctor. The enrollment goal for this study is 549 patients.
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