Pharmos Corporation: A double-blind, randomized, placebo-controlled phase 2b study of 100, 200, and 300 mg BID dextofisopam in female outpatients with irritable bowel syndrome (IBS)

IRB# HUM13638
Principal Invesitgator: William Chey, MD, pager 5684
Contact: Lina Nahlawi, pager: 0321, phone: 734-936-2761, lnahlawi@med.umich.edu

Study Drug
Dextofisopam is the R-enantiomer of RS-tofisopam, which is approved and used outside the US for treating a variety of disorders related to autonomic 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 2-week treatment-free screening period, a 12-week blinded treatment period, followed by a treatment-free withdrawal period, and requires 6 visits to the research office. Study procedures include: physical exam, vital signs, lab testing, and ECG.

Compensation
$50 for each completed visit, a total of $300 for completing the whole study.

Subject Eligibility:

• female age 18–65
• diagnosed with diarrhea or alternating – IBS
• must not have history of suicide ideation
• must not have history of seizures
• must not have history of head trauma with loss of consciousness
• must not have psychotic disorder
• BMI <40
• must not have diabetes type I
• must not have had an MI within the past 5 years, or significant ECG abnormalities

AGI Therapeutics Research Ltd: A randomized, double-blind, placebo-controlled study of AGI-003 (arverapamil) in the treatment of irritable bowel syndrome with diarrhea (IBS-D)

IRB# HUM00016350
Principal Investigator: William Chey, MD, pager 5684
Study Coordinator: Lina, pager: 0321, Tel: 734.936.2761, lnahlawi@med.umich.edu

Study Objective
To determine the efficacy of AGI-003 (arverapamil) in the treatment of IBS-D during an active phase of diarrhea.

Study Drug
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
This is a multicenter, randomized, double-blind, placebo-controlled, 4-parallel group trial. A total of 1200 patients will be included who meet the Rome III criteria for IBS-D. Participants will record their daily bowel habits using the IVRS.  There will be a 2-week screening period followed by a 12-week treatment period during which subjects will return once a month to the research office.  Study procedures include: physical exam, vital signs, ECG, and clinical lab tests.

Subject Eligibility:

• Adults ages 18–70 years old
• Diagnosed with diarrhea IBS
• Hypotension, cardiac arrhythmias, L ventricular dysfunction
• Barrett’s and/or Grade III esophagitis
• Antibiotic use within one month prior to screening (prophylactic use of antibiotic is allowed if  on stable dose for > 3 months)
• Past or present alcohol or drug abuse.

Compensation: $25 for each visit, $125 for completing the study