Expired Study
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Clinical Trial 10292

Tucson, AZ 85710

Study Summary:

The purpose of the study is to evaluate the efficacy and safety of a new investigational mesalamine (5-ASA) 1 g suppository (study medication) as compared to placebo in adults with mild to moderate ulcerative colitis (disease located in the rectum). Patients found to be eligible will be randomized to receive either the medication, Canasa 1g suppositories or, Placebo suppositories once daily at bedtime for 6 weeks. Upon completion of the first six weeks of investigational treatment you will be given the opportunity to receive the study medication on a voluntary basis for the next 8 weeks of the study depending on the evaluation of the severity of your disease by the study medical doctor at Week 6. 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 clincial 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 treatmentcheck 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.

If you are presently experiencing symptoms of ulcerative proctitis,such as increased frequency of bowel movements and rectal bleeding, you may be eligible to participate in a clinical research study of an investigational medcication for ulcerative proctitis

Qualified Participants May Receive:

Qualified participants will receive physical examinations, lab tests, diagnostic exams, and study medications all at no charge to you. Compensation for time and travel will also be available.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.