xMedica

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 participants recherchés109 sites1 pays

Catégories

Gastro-entérologie et hépatologie100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

Cette étude vous intéresse ?

Se connecter ou créez un compte pour manifester votre intérêt et suivre cette étude.

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.

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

Résumé

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.

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.

Affections

  • Chronic Idiopathic Constipation (CIC)

Éligibilité

SexeTous
Âges18 Years – 80 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement692 participants recherchés

Promoteur et collaborateurs

  • Ardelyx Promoteur

Groupes et interventions

  • 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.

Interventions

  • Médicament Placebo

    Patients will receive matching placebo BID

  • Médicament Tenapanor 25 mg BID

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

  • Médicament Tenapanor 5 mg BID

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

  • Médicament Tenapanor 50 mg BID

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

Critères de jugement

  1. Critère de jugement principal

    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

    Délai 12 Weeks

  2. Critère de jugement secondaire

    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.

    Délai 12 Weeks

  3. Critère de jugement secondaire

    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

    Délai 12 Weeks

  4. Critère de jugement secondaire

    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

    Délai 12 Weeks

  5. Critère de jugement secondaire

    Change from baseline in stool consistency

    Change from baseline over the first 12 weeks of the randomized treatment period in stool consistency

    Délai 12 Weeks

  6. Critère de jugement secondaire

    Change from baseline in stool straining

    Change from baseline over the first 12 weeks of the randomized treatment period in straining

    Délai 12 Weeks

Dates

Date de début13 janvier 2026 (réelle)
Achèvement principal26 février 2027 (estimée)
Achèvement4 juin 2027 (estimée)
Première publication2 février 2026 (réelle)
Dernière mise à jour4 juin 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuin 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

109 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Albuquerque Clinical Trials (ACT)AlbuquerqueNew MexicoEn recrutement
University of Michigan Health SystemAnn ArborMichiganEn recrutement
Agile Clinical Research Trials, LLCAtlantaGeorgiaEn recrutement
DelRicht Clinical Research - AtlantaAtlantaGeorgiaEn recrutement
Elite Clinical Trials-IdahoBlackfootIdahoEn recrutement
Treasure Valley Medical ResearchBoiseIdahoEn recrutement
Accellacare of BristolBristolTennesseeEn recrutement
NY ScientificBrooklynNew YorkEn recrutement
Hope Clinical Research - Canoga ParkCanoga ParkCaliforniaEn recrutement
Accellacare of CaryCaryNorth CarolinaEn recrutement
Arizona Liver Health - ChandlerChandlerArizonaEn recrutement
DelRicht Clinical Research - CharlestonCharlestonSouth CarolinaEn recrutement
Delricht Clinical Research - BadmusCharlotteNorth CarolinaEn recrutement
Charlottesville Medical Research Center, LLCCharlottesvilleVirginiaEn recrutement
Erick H. Alayo Medical CorporationChula VistaCaliforniaEn recrutement
GW Research Inc.Chula VistaCaliforniaEn recrutement
Cleveland ClinicClevelandOhioEn recrutement
Gastrointestinal Associates LLPColumbia FallsMontanaEn recrutement
Centricity Research Columbus Ohio MultispecialtyColumbusOhioEn recrutement
Remington Davis, Inc.ColumbusOhioEn recrutement
Zenos Clinical ResearchDallasTexasEn recrutement
EPIC Medical ResearchDeSotoTexasEn recrutement
Advanced Research Institute - DenverDenverColoradoEn recrutement
3A ResearchEl PasoTexasEn recrutement
Lillestol Research, LLCFargoNorth DakotaEn recrutement
Coastal Research Institute, LLCFayettevilleNorth CarolinaEn recrutement
G & L Research, LLCFoleyAlabamaEn recrutement
Proactive Clinical ResearchFort LauderdaleFloridaEn recrutement
Woodholme GastroenterologyGlen BurnieMarylandEn recrutement
GI Alliance - Glenview, ILGlenviewIllinoisEn recrutement
DelRicht Clinical Research - GulfportGulfportMississippiEn recrutement
Clinical Investigation Specialists, IncGurneeIllinoisEn recrutement
Drug Trials AmericaHartsdaleNew YorkEn recrutement
DelRicht Clinical Research - NashvilleHendersonvilleTennesseeEn recrutement
Peters Medical ResearchHigh PointNorth CarolinaEn recrutement
Tandem Clinical Research GI - HoumaHoumaLouisianaEn recrutement
Hometown Urgent Care and Research - Huber HeightsHuber HeightsOhioEn recrutement
DelRicht Clinical Research - IndianapolisIndianapolisIndianaEn recrutement
310 Clinical ResearchInglewoodCaliforniaEn recrutement
Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonJacksonNew JerseyEn recrutement
Kansas City Research InstituteKansas CityMissouriEn recrutement
Accellacare of KnoxvilleKnoxvilleTennesseeEn recrutement
New Phase Research & Development - KnoxvilleKnoxvilleTennesseeEn recrutement
Rocky Mountain Gastroenterology (RMG) - LittletonLakewoodColoradoEn recrutement
Om Research LLCLancasterCaliforniaEn recrutement
Jubilee Clinical Research, Inc.Las VegasNevadaEn recrutement
Excel Clinical ResearchLas VegasNevadaEn recrutement
Digestive Disease SpecialistsLas VegasNevadaEn recrutement
Clinical Trials ResearchLincolnCaliforniaEn recrutement
Tekton Research - Longmont, COLongmontColoradoEn recrutement

59 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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