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TLynn

IBS-D study enrolling in San Antonio

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TLynn

Sponsor:  OrphoMed, Inc. 

Study Title:  "A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ORP 101 in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D)"

Protocol Number:  OM-201

Participants will be asked to make a total of 8 visits to the study site over 4 months; each visit will take approximately 60 minutes; however the first three visits may take up to 90 minutes.  If  you qualify for the study, you will be randomly assigned (like the flip of a coin) to receive either one of two different doses of ORP-101 (50 or 100mg once a day) or placebo (a treatment that contains no active drug).  Your chance of receiving placebo will be about 40%.  Early in the study, the two doses of ORP-101 will be used equally but later in the study, information from prior subjects may be used to increase the chance that you receive a dose that may work for you.  The study drug will be taken as two 25mg tablets (round) and/or a 100mg tablet (caplet shaped), with matching placebo tablets for both sizes and should be taken as a total of three tablets per dose per day.  You will be told to take study drug swallowed whole (not crushed, chewed, divided, or dissolved) with approximately 8 ounces of water on an empty stomach, approximately 30 minutes before breakfast.

 

Synexus (www.synexus.com) in San Antonio is conducting this study.  You can prescreen through our sister company, Acurian, at www.synexusstudies.com to see if you may qualify.

 

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