The COMPOSE study is a clinical research study evaluating an oral investigational drug for constipation. It is designed specifically for people taking prescription pain medication to manage chronic pain. Researchers are evaluating the investigational drug to see if it may potentially relieve constipation by increasing the frequency of bowel movements.
You will be randomly assigned (like flipping a coin) to receive either the investigational drug or placebo. You will have a 50 percent chance of receiving the investigational drug, and a 50 percent chance of receiving the placebo. Both are taken as oral tablets.
Study participants will continue to see their regular doctor for the management of their chronic pain.
There is no cost to participate and
health insurance is not required.
About Clinical Research Studies
Clinical research studies like the COMPOSE study play an important part of the development of future medical treatments. They are conducted to test investigational drugs to determine if they are safe and effective.
Participation in a clinical research study is always voluntary. If you decide to participate, you may withdraw at any time and for any reason. If you decide not to participate, your decision will not affect the care you are receiving now or that you may receive in the future.
You may be eligible to participate if you:
- Have had non-cancer-related pain for three months or longer, and have been taking a prescription pain medication for at least one month
- Have, on average, fewer than three bowel movements a week
- Have tried a laxative or currently taking laxatives to treat constipation caused by prescription pain medication
If you qualify and choose to participate, you will receive the following at no cost:
- Comprehensive study-related consultation with the study doctor
- Investigational drug or placebo (an inactive substance)
- Study-related visits, care, and monitoring