Trial InformationSummary: Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety,Tolerability and Effect of Mitemcinal Fumarate in the Treatment of Constipation-Predominant Irritable Bowel SyndromeThis study is intended to evaluate the potential to relieve the symptoms associated with constipation-predominant Irritable Bowel Syndrome during 12 Weeks of treatment with oral tablets given twice a day of mitemcinal 5mg and placebo (an inactive substance). Additionally, the study will evaluate the safety and tolerability of mitemcinal compared to placebo in patients with constipation-predominant Irritable Bowel Syndrome. Inclusion Criteria Must be 18 years of age or older. Must have at least a 3-month history of constipation-predominant Irritable Bowel Syndrome as diagnosed by Rome II Criteria. See Appendix III. If you are 50 years of age or older, normal colonic anatomy as documented by colonoscopy, double-contrast barium enema, or flexible sigmoidoscopy performed within the previous 5 years. You must provide complete responses to > 75% of weekly assessments (i.e., 3 of 4) during the 4-week baseline screening period. You must have at least mild abdominal pain/discomfort as determined by a baseline mean score of > 25 mm on the 100 mm VAS during the screening period. You must complete the screening LBT with an abnormal finding. If female, you must be surgically sterile post-menopausal (no menses > 12 months), or using an effective method of contraception. You must be able and willing to provide informed consent.Exclusion Criteria Laxatives during the 2 weeks immediately prior to randomization (except “fiber†or “bulking†agents taken on a stable regimen for at least 3 months prior to screening and the same regimen is intended to be maintained stable for the duration of the study). Use of laxatives within 2 weeks prior to screening and during the first two weeks during screening should be avoided if possible. Use any of the following drugs within 2 weeks prior to or during screening
rokinetic agents (e.g., tegaserod, metoclopramide, erythromycin, domperidone, cisapride). Antifungal agents (e.g., fluconazole, itraconazole, ketoconazole). Antiarrhythmic agents known to be associated with QT prolongation (e.g., quinidine, procainamide, disopyramide, dofetilide, ibutilide, sotalol). Medication containing an opiate. Macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin). Anti-spasmodics (e.g., glycopyrrolate, atropine, hyoscyamine, scopolamine).History of any of the following gastrointestinal conditions:Inflammatory Bowel Disease (IBD). Bowel surgery (except appendectomy or gall bladder removal > 3 months prior to screening). Known bowel obstruction or adhesions.QTc Prolongation. Diabetes mellitus Type 1 or 2. Parkinson’s disease. Thyroid disease not stable. Kidney failure defined as creatinine 3.0 mg/dl. History of cirrhosis. Acute or chronic liver disease/infection. Active gallstone disease. Current abuse of drug or alcohol, as determined by the Investigator. Major psychiatric illness not currently under stable medical control. You have taken antibiotics within 2 months prior to screening. Participated in a clinical drug study within 30 days prior to screening. Pregnant (positive urine or serum test) or breast-feeding. Laboratory abnormality or unstable medical or surgical condition that is deemed clinically significant in the opinion of the Investigator. Allergy or significant intolerance to erythromycin, clarithromycin or azithromycin Unable or unwilling to abide by the protocol.Contact:Yuthana Kong, Study CoordinatorCedars-Sinai Medical Center8635 W. 3rd Street, Suite 770WLos Angeles, CA 90048Telephone: 310-423-3792Fax: 310-423-2404Email: kongy###cshs.org Provided byMapQuest
