The ACCEL clinical research study is for adults who are living with chronic idiopathic constipation (CIC), also called functional constipation (FC). If you’ve been struggling with infrequent, difficult, or incomplete bowel movements for more than 3 months, you’re not alone. The ACCEL study is designed to evaluate an investigational treatment that may help improve symptoms of chronic constipation.
18-80 years old
Chronic idiopathic constipation (CIC)
Yes
3
32 weeks
Study participants may be able to join the study if they meet the following requirements:
18-80 years old
Experience chronic constipation
(defined as having fewer than 3 bowel movements each week for at least 3 months)
Have not been diagnosed with irritable bowel syndrome
(IBS, IBS-C, IBS-D, IBS-M)
Other study requirements will apply.
Participation in the ACCEL study lasts about lasts about 32 weeks. Study participants can expect the following:
1
1
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures.
2
2
Receive study health assessments to determine if you qualify for the study, such as a physical exam, blood tests, urine tests, and an ECG. You will record your symptoms (every day) and constipation severity (once per week) in an electronic diary (eDiary).
3
3
Take study medication tablets orally twice per day prior to breakfast and prior to dinner for the duration of the study medication period. You will continue to fill out information on constipation symptoms and severity in your eDiary.
4
4
Continue to receive additional study health assessments at the site.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study medication, tenapanor, is designed to reduce the amount of sodium (salt) absorption that happens in your gastrointestinal (GI) system. By keeping more salt in your GI system, more water is retained there. This increase in water can help soften your bowel movements, resulting in an increase in frequency and making them easier to pass.
Tenapanor is currently approved in the U.S. for adult patients with IBS-C.
Some participants will receive placebo, which is a tablet that looks like tenapanor but has no active ingredients. You will not know if you are receiving tenapanor or placebo, but you will have the same study support and health monitoring regardless. Your chance of receiving the study medication is 3 out of 4 chance or 75% while your chance of receiving placebo is 1 out of 4 or 25%.
Investigational means the study medication is not yet approved by regulatory authorities like the US Food and Drug Administration (FDA) for the treatment of Chronic Idiopathic Constipation, and it can only be used in clinical research studies like ACCEL.
Constipation means it’s hard to have a bowel movement (poop). With constipation, you may go less than usual, have difficult bowel movements, which may be difficult to pass.
Constipation is common and can happen to anyone, but chronic constipation means your constipation lasts for a long time.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study center near you.
Use the filters, map, and listing to find the study center closest to you.