NCT07382167 · Ardelyx
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
What this study is about
This is a 26-week, multi-center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study with a 4-week treatment-free Safety Follow-up period to assess the safety and effectiveness of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
View original scientific description
This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
- Meet the Rome IV Diagnostic Criteria for functional constipation.
- Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication.
- Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
- Meets the entry criteria assessed during the Screening period.
- Ability to understand and provide input on the assessments in the eDiary.
- Provide written informed consent before the initiation of any study-specific procedures.
- Must agree to have daily access to eDiary via a computer, tablet or smart phone
Exclusion criteria
- Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit
- Fecal impaction within 6 months prior to the Screening visit
- Unexplained and clinically significant alarm symptoms.
- Functional diarrhea as defined by Rome IV criteria
- IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
- Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
- Patient with central nervous system disorder
- Use of prohibited medications defined by protocol
- Patient has a history or current evidence of laxative abuse
- Hepatic dysfunction
- Positive HIV, hepatitis B or hepatitis C test at screening
- Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD)
- Any evidence of or treatment of malignancy within 1 year prior to the Screening visit
- Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit
- Pregnant women or women planning to become pregnant during trial participation
- A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit.
- Alcohol or substance abuse within 1 year prior to the Screening visit
- Participation in other clinical trials within 1 month prior to the Screening visit
- Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial
Where
- Foley, Alabama
- Saraland, Alabama
- Chandler, Arizona
- Phoenix, Arizona
- Sun City West, Arizona
- Tucson, Arizona
- North Little Rock, Arkansas
- Canoga Park, California
- Chula Vista, California
- Inglewood, California
- Lancaster, California
- Lincoln, California
And 89 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations