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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 692 مشاركاً109 مواقعدولة واحدة

الفئات

أمراض الجهاز الهضمي والكبد100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Chronic Idiopathic Constipation (CIC)

الأهلية

الجنسالجميع
الأعمار18 Years – 80 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 692 مشاركاً

الجهة الراعية والمتعاونون

  • Ardelyx الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • دواء Placebo

    Patients will receive matching placebo BID

  • دواء Tenapanor 25 mg BID

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

  • دواء Tenapanor 5 mg BID

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

  • دواء Tenapanor 50 mg BID

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

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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

    الإطار الزمني 12 Weeks

  2. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 12 Weeks

  3. مقياس النتيجة الثانوي

    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

    الإطار الزمني 12 Weeks

  4. مقياس النتيجة الثانوي

    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

    الإطار الزمني 12 Weeks

  5. مقياس النتيجة الثانوي

    Change from baseline in stool consistency

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

    الإطار الزمني 12 Weeks

  6. مقياس النتيجة الثانوي

    Change from baseline in stool straining

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

    الإطار الزمني 12 Weeks

التواريخ

تاريخ البدء13 يناير 2026 (فعلي)
الإتمام الأولي26 فبراير 2027 (تقديري)
الإتمام4 يونيو 2027 (تقديري)
أول نشر2 فبراير 2026 (فعلي)
آخر تحديث4 يونيو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيونيو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

109 مواقع قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Albuquerque Clinical Trials (ACT)AlbuquerqueNew Mexicoقيد التجنيد
University of Michigan Health SystemAnn ArborMichiganقيد التجنيد
Agile Clinical Research Trials, LLCAtlantaGeorgiaقيد التجنيد
DelRicht Clinical Research - AtlantaAtlantaGeorgiaقيد التجنيد
Elite Clinical Trials-IdahoBlackfootIdahoقيد التجنيد
Treasure Valley Medical ResearchBoiseIdahoقيد التجنيد
Accellacare of BristolBristolTennesseeقيد التجنيد
NY ScientificBrooklynNew Yorkقيد التجنيد
Hope Clinical Research - Canoga ParkCanoga ParkCaliforniaقيد التجنيد
Accellacare of CaryCaryNorth Carolinaقيد التجنيد
Arizona Liver Health - ChandlerChandlerArizonaقيد التجنيد
DelRicht Clinical Research - CharlestonCharlestonSouth Carolinaقيد التجنيد
Delricht Clinical Research - BadmusCharlotteNorth Carolinaقيد التجنيد
Charlottesville Medical Research Center, LLCCharlottesvilleVirginiaقيد التجنيد
Erick H. Alayo Medical CorporationChula VistaCaliforniaقيد التجنيد
GW Research Inc.Chula VistaCaliforniaقيد التجنيد
Cleveland ClinicClevelandOhioقيد التجنيد
Gastrointestinal Associates LLPColumbia FallsMontanaقيد التجنيد
Centricity Research Columbus Ohio MultispecialtyColumbusOhioقيد التجنيد
Remington Davis, Inc.ColumbusOhioقيد التجنيد
Zenos Clinical ResearchDallasTexasقيد التجنيد
EPIC Medical ResearchDeSotoTexasقيد التجنيد
Advanced Research Institute - DenverDenverColoradoقيد التجنيد
3A ResearchEl PasoTexasقيد التجنيد
Lillestol Research, LLCFargoNorth Dakotaقيد التجنيد
Coastal Research Institute, LLCFayettevilleNorth Carolinaقيد التجنيد
G & L Research, LLCFoleyAlabamaقيد التجنيد
Proactive Clinical ResearchFort LauderdaleFloridaقيد التجنيد
Woodholme GastroenterologyGlen BurnieMarylandقيد التجنيد
GI Alliance - Glenview, ILGlenviewIllinoisقيد التجنيد
DelRicht Clinical Research - GulfportGulfportMississippiقيد التجنيد
Clinical Investigation Specialists, IncGurneeIllinoisقيد التجنيد
Drug Trials AmericaHartsdaleNew Yorkقيد التجنيد
DelRicht Clinical Research - NashvilleHendersonvilleTennesseeقيد التجنيد
Peters Medical ResearchHigh PointNorth Carolinaقيد التجنيد
Tandem Clinical Research GI - HoumaHoumaLouisianaقيد التجنيد
Hometown Urgent Care and Research - Huber HeightsHuber HeightsOhioقيد التجنيد
DelRicht Clinical Research - IndianapolisIndianapolisIndianaقيد التجنيد
310 Clinical ResearchInglewoodCaliforniaقيد التجنيد
Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonJacksonNew Jerseyقيد التجنيد
Kansas City Research InstituteKansas CityMissouriقيد التجنيد
Accellacare of KnoxvilleKnoxvilleTennesseeقيد التجنيد
New Phase Research & Development - KnoxvilleKnoxvilleTennesseeقيد التجنيد
Rocky Mountain Gastroenterology (RMG) - LittletonLakewoodColoradoقيد التجنيد
Om Research LLCLancasterCaliforniaقيد التجنيد
Jubilee Clinical Research, Inc.Las VegasNevadaقيد التجنيد
Excel Clinical ResearchLas VegasNevadaقيد التجنيد
Digestive Disease SpecialistsLas VegasNevadaقيد التجنيد
Clinical Trials ResearchLincolnCaliforniaقيد التجنيد
Tekton Research - Longmont, COLongmontColoradoقيد التجنيد

يُدرَج 59 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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