Despite the fact that there are between 25-45 million people in the US with IBS-D, there are very few antidiarrheal medicines available.
When IBS-D occurs, there are only three over-the-counter medications (Imodium, Pepto Bismol, Kaopectate) to choose from. For prescription medicines, there are only three drugs that are FDA-approved for IBS-D (Lotronex, Viberzi, and Xifaxan). It’s clear that new studies are needed to expand the list of drugs for IBS-D.
Clinical trials are key for discovering new treatments. They help inform researchers of what works, what doesn’t, and at what dose a drug is effective in treating a condition. But clinical trials of new therapies are only successful if there are enough diverse people participating in the study.
Pharmaceutical companies sometimes contract the study to third-party organizations, such as a university medical centers or a clinical research organization (CRO). Contracting out research reduces costs for companies and simplifies the clinical research or study process. They also help to recruit and retain participants for the studies.
AcurianHealth is a CRO that helps connect diverse people to clinical studies that are still under development. Recently, AcurianHealth reached out to the IBS community about the PREVAIL study on a new medication for IBS-D.
The PREVAIL study is designed to assess the safety and effectiveness of ORP-101, a unique compound that could improve abdominal pain, stool consistency, and bowel incontinence. Participants will be assigned to one of three study groups. Two of the three patient groups will take the investigational drug (in tablet form) and the third group will receive a placebo.
All study participants will undergo a physical examination, electrocardiogram (ECG), and blood and urine samples. The trial study should last about 19 weeks and participants will need to visit the clinic several (eight) times. Individuals who participate will be reimbursed for travel and their time.
To participate in the clinical trial, individuals must:
· Be 18 - 75 years old,
· Have abdominal pain
· Have frequent diarrhea
There’s a chance this new investigational drug may significantly improve IBS-D for many. But they must first qualify to participate. To learn more about the study, visit the research website here.
Interested in learning more about in clinical studies? Check out our article on getting access to new therapies!