Is chronic constipation holding you back? You may qualify to enroll in the ACCEL study.

What is the ACCEL study?

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, even after trying a high fiber diet or over-the-counter laxatives, you're not alone. The ACCEL study is designed to evaluate an investigational treatment that may help improve symptoms of chronic constipation.

Who can join the ACCEL study?

Study participants may be able to join the study if they meet the following requirements:

• 18 to 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

What will happen during the study?

Participation in the ACCEL study lasts about 32 weeks. Study participants can expect the following:

1. 1

   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.

2. 2

   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).

3. 3

   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.

4. 4

   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.