Tenapanor for Chronic Constipation

Recruiting at 31 trial locations

Overseen By Jocelyn Tabora

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ardelyx

Must not be taking: Prohibited medications

Disqualifiers: IBS, CNS disorders, Hepatic dysfunction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

692 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Susan Edelstein, PhD

Principal Investigator

Ardelyx Inc

Are You a Good Fit for This Trial?

Adults aged 18-80 with Chronic Idiopathic Constipation (CIC) who meet the Rome IV criteria for functional constipation can join. They must agree to use contraception if applicable, be able to interact with an eDiary, and provide consent. Those unable or unwilling to follow these requirements cannot participate.

Inclusion Criteria

I am between 18 and 80 years old.

I have signed the consent form for this study.

I can access an eDiary daily using a digital device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive tenapanor or placebo twice daily for 26 weeks, with regular safety assessments and symptom monitoring

26 weeks

Visits every 2 to 6 weeks (in-person)

Follow-up

Participants are monitored for adverse events during a treatment-free period

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tenapanor

Trial Overview

The study is testing three different doses of Tenapanor (5 mg, 25 mg, and 50 mg) against a placebo in adults with CIC. Participants will take their assigned treatment twice daily for 26 weeks in this randomized, double-blind trial.

How Is the Trial Designed?

Group I: Tenapanor 50 mg BID Experimental Treatment 1 Intervention

Patients will be randomized to receive 50 mg tenapanor twice daily.

Group II: Tenapanor 5 mg BID Experimental Treatment 1 Intervention

Patients will be randomized to receive 5 mg tenapanor twice daily.

Group III: Tenapanor 25 mg BID Experimental Treatment 1 Intervention

Patients will be randomized to receive 25 mg tenapanor twice daily.

Group IV: Placebo Comparator Placebo Group 1 Intervention

Patients will be randomized to receive matching placebo twice daily.

Who Is Running the Clinical Trial?

Ardelyx

Lead Sponsor

Trials

31

Recruited

6,100+