ACCEL Study: Chronic Idiopathic Constipation (Ages 18–80)
Researchers are investigating a potential treatment for chronic idiopathic constipation (also called functional constipation) in adults. See if you may qualify for the ACCEL study.
- Ages
- 18 – 80 years
- Sex
- All
- Visits
- ~10
- Study ID
- NCT07382167
About this study
The ACCEL clinical research study is for adults living with chronic idiopathic constipation (CIC), also called functional constipation (FC). It is evaluating an investigational treatment that may help improve symptoms of chronic constipation. Participation lasts about 32 weeks across screening, treatment, and follow-up periods.
You may qualify if
- 18 to 80 years old
- Chronic constipation: fewer than 3 bowel movements per week for at least 3 months
- Willing to be contacted by a study site
You may not qualify if
- Diagnosed with irritable bowel syndrome (IBS, IBS-C, IBS-D, IBS-M)
- Significant abdominal pain related to bowel movements that goes away after the bowel movement
- Participated in another clinical trial in the past month
What will happen during the study
Review & sign the Informed Consent Form
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures.
Screening Period (about 2 weeks)
Receive study health assessments to determine if you qualify, such as a physical exam, blood tests, urine tests, and an ECG. You will record your symptoms daily and constipation severity weekly in an electronic diary (eDiary).
Study Medication Period (about 6 months)
Take the study medication tablets orally twice per day — before breakfast and before dinner. You will continue to record symptoms and severity in your eDiary.
Follow-Up Period (about 4 weeks)
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.
About the study medication
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, making them more frequent and easier to pass. Tenapanor is currently approved in the U.S. for adult patients with IBS-C.
Some participants will receive placebo, which looks like the study medication but has no active ingredients. Your chance of receiving the study medication is 3 out of 4 (75%), and your chance of receiving placebo is 1 in 4 (25%). You will not know which you receive, but you will have the same study support and health monitoring regardless.
Not the right study for you? The participation process and the volunteer registry stay open for future studies.
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