NCT07382167ClinicalTrials.gov

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

A 26-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults

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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…

Phase 3692 Teilnehmende gesucht109 Studienzentren1 Land

Kategorien

Gastroenterologie und Hepatologie100%

In 1 Register registriert

ClinicalTrials.govNCT07382167Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 20 days after the recorded start)First posted 2026-02-02; recorded start 2026-01-13
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (Ardelyx)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 109 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 692 participants (target), run at 109 sites.

How this score is built

Enrolment28/40
692 participants (target)
Site count23/25
109 sites
Country count0/15
Single country
Planned duration6/10
Planned over about 17 months
Sponsor scale2/10
Ardelyx has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

This study consists of a 2-week Screening period, followed by a 26-week randomized treatment period (RTP), and a 4-week treatment-free Safety Follow-up period. After obtaining study informed consent from patients, the 2-week Screening period starts. Patients will be fully assessed for eligibility into the study. The assessments will include evaluation of inclusion/exclusion criteria, including medical histories, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Patients will also self-report, on information about the status of their constipation symptoms and severity via an electronic diary (eDiary). Patient compliance with the eDiary will be monitored to determine eligibility at the end of screening. Eligible patients will be randomized (Visit 2) to receive tenapanor 5 mg BID (twice a day), 25 mg BID, 50 mg BID, or placebo for 26 consecutive weeks as the double-blind RTP. During this period, patients will continue recording daily assessments of constipation symptoms and weekly assessments of constipation severity in the eDiary. Patients will have return visits every two to six weeks at Weeks 2, 4, 8, 12, 16, 20 and 26(Visit 3-9) to undergo safety assessments. Upon completion of the 26-week RTP, patients will be monitored for AEs (adverse events) during the 4-week treatment-free Safety Follow-up period and complete the Follow-up visit (Visit 10) at the end of this period to undergo safety assessments.

Erkrankungen

Chronic Idiopathic Constipation (CIC)

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 80 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: 1. Patients ≥18 to ≤80 years old at the Screening visit (Visit 1). 2. Meet the Rome IV Diagnostic Criteria for functional constipation. 3. 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. 4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization. 5. Meets the entry criteria assessed during the Screening period. 6. Ability to understand and provide input on the assessments in the eDiary. 7. Provide written informed consent before the initiation of any study-specific procedures. 8. Must agree to have daily access to eDiary via a computer, tablet or smart phone Exclusion Criteria: 1. 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 2. Fecal impaction within 6 months prior to the Screening visit 3. Unexplained and clinically significant alarm symptoms. 4. Functional diarrhea as defined by Rome IV criteria 5. IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria 6. Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit 7. Patient with central nervous system disorder 8. Use of prohibited medications defined by protocol 9. Patient has a history or current evidence of laxative abuse 10. Hepatic dysfunction 11. Positive HIV, hepatitis B or hepatitis C test at screening 12. Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD) 13. Any evidence of or treatment of malignancy within 1 year prior to the Screening visit 14. Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit 15. Pregnant women or women planning to become pregnant during trial participation 16. A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit. 17. Alcohol or substance abuse within 1 year prior to the Screening visit 18. Participation in other clinical trials within 1 month prior to the Screening visit 19. Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	692 Teilnehmende gesucht

Sponsor und Mitwirkende

Ardelyx Sponsor

Studienarme und Interventionen

Tenapanor 5 mg BIDEXPERIMENTAL
Patients will be randomized to receive 5 mg tenapanor twice daily.
Tenapanor 25 mg BIDEXPERIMENTAL
Patients will be randomized to receive 25 mg tenapanor twice daily.
Tenapanor 50 mg BIDEXPERIMENTAL
Patients will be randomized to receive 50 mg tenapanor twice daily.
Placebo ComparatorPLACEBO_COMPARATOR
Patients will be randomized to receive matching placebo twice daily.

Interventionen

Arzneimittel Placebo
Patients will receive matching placebo BID
Arzneimittel Tenapanor 25 mg BID
Patients will receive tenapanor 25 mg BID (total of 50 mg daily)
Arzneimittel Tenapanor 5 mg BID
Patients will receive tenapanor 5 mg BID (total of 10 mg daily)
Arzneimittel Tenapanor 50 mg BID
Patients will receive tenapanor 50 mg BID (total of 100 mg daily)

Endpunkte

Primärer Endpunkt
Durable complete spontaneous bowel movements (CSBM) response
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
Zeitrahmen 12 Weeks
Sekundärer Endpunkt
9/12 week complete spontaneous bowel movements (CSBM) response
9/12 week complete spontaneous bowel movements (CSBM) response defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period.
Zeitrahmen 12 Weeks
Sekundärer Endpunkt
Change from baseline in complete spontaneous bowel movements (CSBM) frequency
Change from baseline over the first 12 weeks of the randomized treatment period in complete spontaneous bowel movements (CSBM) frequency
Zeitrahmen 12 Weeks
Sekundärer Endpunkt
Change from baseline in spontaneous bowel movement (SBM) frequency
Change from baseline over the first 12 weeks of the randomized treatment period in spontaneous bowel movement (SBM) frequency
Zeitrahmen 12 Weeks
Sekundärer Endpunkt
Change from baseline in stool consistency
Change from baseline over the first 12 weeks of the randomized treatment period in stool consistency
Zeitrahmen 12 Weeks
Sekundärer Endpunkt
Change from baseline in stool straining
Change from baseline over the first 12 weeks of the randomized treatment period in straining
Zeitrahmen 12 Weeks

Daten

Daten
Startdatum	13. Januar 2026 (tatsächlich)
Primärer Abschluss	26. Februar 2027 (geschätzt)
Abschluss	4. Juni 2027 (geschätzt)
Erstveröffentlichung	2. Februar 2026 (tatsächlich)
Zuletzt aktualisiert	4. Juni 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

109 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Albuquerque Clinical Trials (ACT)	Albuquerque	New Mexico	Rekrutiert
University of Michigan Health System	Ann Arbor	Michigan	Rekrutiert
Agile Clinical Research Trials, LLC	Atlanta	Georgia	Rekrutiert
DelRicht Clinical Research - Atlanta	Atlanta	Georgia	Rekrutiert
Elite Clinical Trials-Idaho	Blackfoot	Idaho	Rekrutiert
Treasure Valley Medical Research	Boise	Idaho	Rekrutiert
Accellacare of Bristol	Bristol	Tennessee	Rekrutiert
NY Scientific	Brooklyn	New York	Rekrutiert
Hope Clinical Research - Canoga Park	Canoga Park	California	Rekrutiert
Accellacare of Cary	Cary	North Carolina	Rekrutiert
Arizona Liver Health - Chandler	Chandler	Arizona	Rekrutiert
DelRicht Clinical Research - Charleston	Charleston	South Carolina	Rekrutiert
Delricht Clinical Research - Badmus	Charlotte	North Carolina	Rekrutiert
Charlottesville Medical Research Center, LLC	Charlottesville	Virginia	Rekrutiert
Erick H. Alayo Medical Corporation	Chula Vista	California	Rekrutiert
GW Research Inc.	Chula Vista	California	Rekrutiert
Cleveland Clinic	Cleveland	Ohio	Rekrutiert
Gastrointestinal Associates LLP	Columbia Falls	Montana	Rekrutiert
Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio	Rekrutiert
Remington Davis, Inc.	Columbus	Ohio	Rekrutiert
Zenos Clinical Research	Dallas	Texas	Rekrutiert
EPIC Medical Research	DeSoto	Texas	Rekrutiert
Advanced Research Institute - Denver	Denver	Colorado	Rekrutiert
3A Research	El Paso	Texas	Rekrutiert
Lillestol Research, LLC	Fargo	North Dakota	Rekrutiert
Coastal Research Institute, LLC	Fayetteville	North Carolina	Rekrutiert
G & L Research, LLC	Foley	Alabama	Rekrutiert
Proactive Clinical Research	Fort Lauderdale	Florida	Rekrutiert
Woodholme Gastroenterology	Glen Burnie	Maryland	Rekrutiert
GI Alliance - Glenview, IL	Glenview	Illinois	Rekrutiert
DelRicht Clinical Research - Gulfport	Gulfport	Mississippi	Rekrutiert
Clinical Investigation Specialists, Inc	Gurnee	Illinois	Rekrutiert
Drug Trials America	Hartsdale	New York	Rekrutiert
DelRicht Clinical Research - Nashville	Hendersonville	Tennessee	Rekrutiert
Peters Medical Research	High Point	North Carolina	Rekrutiert
Tandem Clinical Research GI - Houma	Houma	Louisiana	Rekrutiert
Hometown Urgent Care and Research - Huber Heights	Huber Heights	Ohio	Rekrutiert
DelRicht Clinical Research - Indianapolis	Indianapolis	Indiana	Rekrutiert
310 Clinical Research	Inglewood	California	Rekrutiert
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson	Jackson	New Jersey	Rekrutiert
Kansas City Research Institute	Kansas City	Missouri	Rekrutiert
Accellacare of Knoxville	Knoxville	Tennessee	Rekrutiert
New Phase Research & Development - Knoxville	Knoxville	Tennessee	Rekrutiert
Rocky Mountain Gastroenterology (RMG) - Littleton	Lakewood	Colorado	Rekrutiert
Om Research LLC	Lancaster	California	Rekrutiert
Jubilee Clinical Research, Inc.	Las Vegas	Nevada	Rekrutiert
Excel Clinical Research	Las Vegas	Nevada	Rekrutiert
Digestive Disease Specialists	Las Vegas	Nevada	Rekrutiert
Clinical Trials Research	Lincoln	California	Rekrutiert
Tekton Research - Longmont, CO	Longmont	Colorado	Rekrutiert

59 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT07382167