Concorde Clinical Trials

Trials actively enrolling patients:

• Irritable Bowel Syndrome-Diarrhea Predominant sponsored by Salix Pharmaceuticals. This is a Phase 2, randomized, placebo- controlled 12 week study to assess the efficacy and safety of mesalamine daily for the treatment of IBS-D. Patients will be randomized to one of 3 arms: 2 capsules (750mg) of mesalamine daily, 4 capsules (1500mg) of mesalamine daily or 4 placebo capsules daily for 12 weeks. Patients will come in for a total of 6 study visits. If patients have not had colonoscopy within the past 5 years, one will be provided by the sponsor.
• Irritable Bowel Syndrome-Diarrhea Predominant - sponsored by Furiex Pharmaceuticals. This is a Phase 2, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of JNJ-27018966, which is a locally active mixed mu-opioid receptor agonist/delta-opioid receptor antagonist for IBS- D. It is an 18 week study encompassing 8 study visits. Patients will be randomized 80:20 to various dosages of study drug:placebo.
• Proctitis/Proctosigmoiditis - sponsored by Salix Pharmaceuticals. This is a Phase 3, randomized, double-blind placebo-controlled trial to assess the safety and efficacy of budesonide foam for patients with mild to moderate ulcerative proctitis or proctosigmoiditis. Patients will be randomized 50:50 to placebo or active treatment arm. Treatment will be given for 6 weeks for a total of 8 study visits. Patients will have 2 sigmoidoscopies - one at baseline and one at the final visit.

Please support your clinical trials program. If you have a patient who might be eligible for actively enrolling trials, please contact:

Maureen Haskins (mhaskins @ concordemed dot com)

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