Ardexyl 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.
Study Overview
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.
Condition for the trial (i): chronic idiopathic constipation (CIC)
The condition is the disease, disorder, syndrome, or illness that is being looked at in this clinical trial.
Clinical trials are done in different phases. Phase 1 trials are done in a small group of healthy people to see if a new drug is safe. Phase 2, 3, and 4 trials are done in larger groups of patients who have the disease or condition being looked at to see how well it works and to get more safety information.
Who can participate?
Study participants may be able to join the study if they meet the following requirements:
· //age range per protocol (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
What can I expect if I enroll in 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
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).
Study Medication Period
Take //number of doses per protocol (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.
Follow Up Period
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.