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A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

NCT07382167 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2026-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Idiopathic Constipation (CIC)

Interventions

DRUG

Tenapanor 5 mg BID

Patients will receive tenapanor 5 mg BID (total of 10 mg daily)

DRUG

Tenapanor 25 mg BID

Patients will receive tenapanor 25 mg BID (total of 50 mg daily)

DRUG

Tenapanor 50 mg BID

Patients will receive tenapanor 50 mg BID (total of 100 mg daily)

DRUG

Placebo

Patients will receive matching placebo BID

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • Susan Edelstein, PhD · Ardelyx Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2027-02-26
Completion
2027-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382167 on ClinicalTrials.gov