Living with ulcerative colitis (UC) is never easy, especially when it is flaring. For that reason, having effective treatments for UC is very important to those who suffer from it.
Some patients with ulcerative colitis are prescribed medications that do not provide adequate symptom relief, only help for a short time, or have unacceptable side effects. Because the symptoms of UC can be so disruptive, obtaining consistent symptom relief is necessary to getting the lives of many UC patients back on track. Therefore, it is important that the pharmaceutical industry continues to look for new and better treatments.
Conducting medical research through studies like this one is how doctors and drug companies like Protagonist Therapeutics, Inc. learn new information about potential medications. Participation of study volunteers is an essential part of the process. Please read-on to learn more about this medical research study for UC patients who have tried at least one approved treatment which either did not work or which could not be tolerated due to side effects.
The Purpose of this Research Study
The purpose of the PROPEL research study is to evaluate an investigational oral medication for ulcerative colitis to determine how safe and effective it is. The study drug specifically targets the digestive system rather than circulating mainly through the entire body.
What to Expect
This ulcerative colitis study will involve 9 visits to the study center over a period of approximately 16 weeks.
During the first visit (the “screening visit”), the study requirements as well as the potential risks, benefits and alternatives to participation will be explained in detail. Those wishing to participate after this explanation will be asked to sign a written consent form. Next, various questions, tests, and examinations will be asked and given to determine eligibility to participate in the study.
Study participants will be randomly assigned to receive one of the chosen doses of the study drug or a placebo. A placebo is a capsule that looks like the study drug but does not contain any drug in it, much like a sugar capsule. The process for making the random assignment is similar to drawing straws. The chance of being assigned to receive study drug or placebo will be explained to you by the study doctor or the doctor’s staff. During the 12 weeks the study drug will be taken, the study researchers will conduct tests to see how safe the drug is and how participants in each group respond.
Health Insurance and Participation Costs
Health Insurance is not required to participate.
All medical examinations and assigned study drugs are provided to qualified participants at no cost. Financial compensation may also be provided to cover time and travel expenses related to the research study.
Privacy and Confidentiality Policy: If you pre-qualify for this research study, you will be given a choice to submit your contact information along with your answers to the preliminary questionnaire to a study clinic conducting this research study for further evaluation. If you make the choice to submit your contact information, your contact information will only be shared with those involved with the medical research study and will not be shared or provided to any other person or business not related to this medical research study. Except as noted above, your name and contact information will not be taken from you and your answers will remain confidential. We will not use your information for any purpose other than to screen you for potential participation in this medical research study. Your answers will be stored electronically and for auditing purposes, any identifying information that you provide to us will remain stored for up to seven years even if you choose not to participate or are not eligible to participate in this medical research study. If you provide your or a friend’s/family member’s email address, the email address will not be provided to anyone other than the person to whom the email was sent as specified in this website. The person in charge of privacy for this website is the Privacy Officer, who may be contacted at The Patient Recruiting Agency, 6207 Bee Cave Road, Suite 288, Austin, Texas 78746 or
to make any updates to your information or to have your information removed.