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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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En resumen

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…

Fase 3692 participantes buscados109 centros1 país

Categorías

Gastroenterología y hepatología100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

  • 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.

Resumen

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.

Afecciones

  • Chronic Idiopathic Constipation (CIC)

Elegibilidad

SexoTodos
Edades18 Years – 80 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción692 participantes buscados

Patrocinador y colaboradores

  • Ardelyx Patrocinador

Grupos e intervenciones

  • 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.

Intervenciones

  • Fármaco Placebo

    Patients will receive matching placebo BID

  • Fármaco Tenapanor 25 mg BID

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

  • Fármaco Tenapanor 5 mg BID

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

  • Fármaco Tenapanor 50 mg BID

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

Variables de resultado

  1. Variable de resultado 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

    Plazo 12 Weeks

  2. Variable de resultado secundaria

    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.

    Plazo 12 Weeks

  3. Variable de resultado secundaria

    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

    Plazo 12 Weeks

  4. Variable de resultado secundaria

    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

    Plazo 12 Weeks

  5. Variable de resultado secundaria

    Change from baseline in stool consistency

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

    Plazo 12 Weeks

  6. Variable de resultado secundaria

    Change from baseline in stool straining

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

    Plazo 12 Weeks

Fechas

Fecha de inicio13 de enero de 2026 (real)
Finalización principal26 de febrero de 2027 (estimada)
Finalización4 de junio de 2027 (estimada)
Primera publicación2 de febrero de 2026 (real)
Última actualización4 de junio de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjunio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

109 centros están en reclutamiento

United States

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

En el registro figuran 59 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

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