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NCT07382167 · ClinicalTrials.gov registry record · Phase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
A Phase 3 study of Chronic Idiopathic Constipation (CIC), sponsored by Ardelyx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 692
- Enrollment target
- 20
- Study locations
NCT07382167: Recruiting Phase 3 study of Chronic Idiopathic Constipation (CIC), sponsored by Ardelyx.
NCT07382167 is a Phase 3 study of Chronic Idiopathic Constipation (CIC) that is actively recruiting participants, run by Ardelyx. The registered enrollment target is 692 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07382167, a Phase 3 study of Chronic Idiopathic Constipation (CIC), is actively recruiting participants, sponsored by Ardelyx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 692 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Durable complete spontaneous bowel movements (CSBM) response is defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period and and for ≥3 of the last 4 weeks of the first 12 weeks of randomized treatment period
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tenapanor 5 mg BID
- DRUG Tenapanor 25 mg BID
- DRUG Tenapanor 50 mg BID
Study Locations (20)
Florida
- Proactive Clinical Research - Fort Lauderdale
- Valencia Medical and Research Center - Miami
- IMIC, Inc - Miami
- Suncoast Clinical Research, Inc. - New Port Richey - New Port Richey
- Sensible Healthcare, LLC - Ocoee
- Harmony Clinical Research - Orlando - Orange City
- Suncoast Clinical Research, Inc. - Palm Harbor - Palm Harbor
- Clinical Research Center of Florida - Pompano Beach
California
- Hope Clinical Research - Canoga Park - Canoga Park
- GW Research Inc. - Chula Vista
- Erick H. Alayo Medical Corporation - Chula Vista
- 310 Clinical Research - Inglewood
- Om Research LLC - Lancaster
- Clinical Trials Research - Lincoln
- Paragon Rx Clinical, Inc. - Santa Ana - Santa Ana
Arizona
- Arizona Liver Health - Chandler - Chandler
- Elite Clinical Studies - Phoenix
Arkansas
- Arkansas Gastroenterology - North Little Rock - North Little Rock
Colorado
- Rocky Mountain Gastroenterology (RMG) - Littleton - Lakewood
Georgia
- Agile Clinical Research Trials, LLC - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 692 participants |
| Start Date | 2026-01-13 |
| Est. Completion | 2027-06-04 |
| Phase | Phase 3 |
What NCT07382167 shows while recruiting
NCT07382167 is an interventional study that assigns participants to a tested intervention. The registered 692 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Chronic Idiopathic Constipation (CIC) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT07382167 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT07382167 about?
NCT07382167 is a clinical study titled "A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults". 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 f...
What is the current status of trial NCT07382167?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 692 participants. The study started on 2026-01-13. Estimated completion is 2027-06-04.
What conditions does trial NCT07382167 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation (CIC).
What interventions are being tested in trial NCT07382167?
The interventions under investigation include: Placebo (DRUG), Tenapanor 5 mg BID (DRUG), Tenapanor 25 mg BID (DRUG), Tenapanor 50 mg BID (DRUG).
Who is sponsoring clinical trial NCT07382167?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07382167 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Idiopathic Constipation (CIC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07382167's enrollment target sits among peer trials
692 520th of 2000 higher than 1,478 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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