About the CAPTIVATE Study
IBS is an intestinal (gut) disorder associated with pain in the belly, gas, and diarrhea and/or constipation. Many people with IBS say abdominal pain is the symptom that bothers them the most.
The CAPTIVATE Study is a clinical study to evaluate how an investigational study medication called olorinab works in people with IBS experiencing abdominal pain. You may be able to take part in the CAPTIVATE Study if you:
- are 18–70 years of age
- have been diagnosed with IBS with constipation or diarrhea (IBS-C or IBS-D)
- experience abdominal pain due to IBS
There are additional criteria that are reviewed by the study team at the study center at the first visit.
Please take a short survey here to see if you pre-qualify now!
The CAPTIVATE Study will involve taking the investigational study treatment (olorinab or placebo), visiting the study center, recording your symptoms in an eDiary (an electronic diary that captures data) every day throughout the study, and completing study procedures. You may visit the study center up to 9 times.
The study centers are located throughout the United States. During this preliminary screening process, you will be asked to answer a short questionnaire to see if you pre-qualify. If you do pre-qualify, you will have the chance to search for study centers in your area using your zip code.
If eligible, participation can last up to 20 weeks and includes up to 9 visits to the study center for study assessments.
This initial appointment is an opportunity for you to:
- Learn more about the CAPTIVATE Study. You’ll be speaking with the study team at the study center to learn more about participation.
- Ask any important questions. These can be any questions you may have about the CAPTIVATE Study or clinical research in general.
- Determine if the CAPTIVATE Study may be right for you. If you agree to be considered for the study, the center will ask you to review and sign a consent form. After you speak with the study team and learn details about the study, they will review some additional study criteria to determine if you are eligible to participate in the study.
The investigational study medication in the CAPTIVATE Study is olorinab, a medication taken 3 times a day. Olorinab is being studied to see whether it may reduce abdominal pain associated with IBS.
If you qualify for the CAPTIVATE Study, you will have a 3-in-4 chance of receiving olorinab and a 1-in-4 chance of receiving placebo (inactive treatment). Neither you nor the study staff will know your assignment.
The investigational study medication has been previously tested in healthy volunteers and in a small group of people with Crohn’s disease experiencing abdominal pain.
Some medications are not allowed. Do not add, discontinue, or change any medication (including prescription or over the counter medicines, herbal medications or supplements), unless you are advised to do so by the study center staff or your primary care physician.
All study medication and study-related care will be provided at no cost to you or your insurance provider for participating in this study. If you qualify for the study, you will be paid for each completed study visit.
One or more of your screening results were outside of the eligibility criteria for this trial. This does not mean you will not qualify for different research studies.