Clinical Trials

Pharmos/Dextofisopam, Phase II-b A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of 100, 200, and 300 mg BID Dextofisopam in Female Outpatients with Irritable Bowel Syndrome, HUM13638

PI: William Chey, M.D., pager 5684
Contact: Lina, pager 0321, Tel: 936-2761, lnahlawi@med.umich.edu

Dextofisopam is the R-enantiomer of RS-tofisopam, which is marketed outside the US for treating a variety of disorders related to autonomic nervous system dysfunction, including IBS. It acts centrally on subcortical benzodiazepine receptors, and may exert anti-inflammatory activity via cytokine inhibition. It reduces stimulated activity and decreases contractions evoked by colorectal distension.

Study Design: A total of 480 patients will be included. 3-months treatment requiring 6 visits. Study procedures include: physical exam, vital signs, lab testing (blood, urine, stool), and ECG.

Compensation: $50/visit

Subject Eligibility:

• female age 18 - 65
• has diarrhea or mixed Ð IBS
• must not have history of suicide ideation, seizures, closed head trauma with loss of consciousness, psychotic disorder
• must insulin-dependent diabetes
• must not have had a MI within the past 5 years, or significant ECG abnormalities

AGI/Arverapamil, Phase III, A Randomized, Double-blind, Placebo-controlled Study of AGI-003 (Arverapamil) in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D), HUM16350

PI: William Chey, M.D., pager 5684
Contact: Lina, pager 0321, Tel: 936-2761, lnahlawi@med.umich.edu

Arverapamil is the R(+) enantiomer of verapamil hydrochloride, which is a well established calcium channel blocker. Racemic verapamil has been reported to have beneficial effects in gastrointestinal conditions associated with diarrhea, including IBS.

Study description: A total of 1200 patients will be included who meet the Rome III criteria for IBS-D. Randomized subjects will receive one of three study drug treatments: 15 mg, 37.5 mg, 75 mg; a fourth group will receive the placebo. 3-months treatment requiring 5 visits. Interested participants may roll over to a one-year open-label extension study. Procedures include: physical exam, vital signs, ECG, and clinical lab tests.

Compensation: $25/visit

Subject Eligibility:

• Male and female adults ages 18-75 years old with diarrhea IBS
• Excluding subjects with hypotension, cardiac arrhythmias, L ventricular dysfunction
• Excluding subjects with BarrettÕs and/or Grade III esophagitis
• Excluding subjects with past or present history of alcohol or drug abuse