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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 692 משתתפים109 אתריםמדינה אחת

קטגוריות

גסטרואנטרולוגיה והפטולוגיה100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Chronic Idiopathic Constipation (CIC)

זכאות

מיןהכול
גילאים18 Years – 80 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 692 משתתפים

נותן חסות ושותפים

  • Ardelyx נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • תרופה Placebo

    Patients will receive matching placebo BID

  • תרופה Tenapanor 25 mg BID

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

  • תרופה Tenapanor 5 mg BID

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

  • תרופה Tenapanor 50 mg BID

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

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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

    מסגרת זמן 12 Weeks

  2. מדד תוצאה משני

    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.

    מסגרת זמן 12 Weeks

  3. מדד תוצאה משני

    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

    מסגרת זמן 12 Weeks

  4. מדד תוצאה משני

    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

    מסגרת זמן 12 Weeks

  5. מדד תוצאה משני

    Change from baseline in stool consistency

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

    מסגרת זמן 12 Weeks

  6. מדד תוצאה משני

    Change from baseline in stool straining

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

    מסגרת זמן 12 Weeks

תאריכים

תאריך התחלה13 בינואר 2026 (בפועל)
סיום ראשוני26 בפברואר 2027 (משוער)
סיום4 ביוני 2027 (משוער)
פורסם לראשונה2 בפברואר 2026 (בפועל)
עודכן לאחרונה4 ביוני 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיוני 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

109 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
Albuquerque Clinical Trials (ACT)AlbuquerqueNew Mexicoמגייס
University of Michigan Health SystemAnn ArborMichiganמגייס
Agile Clinical Research Trials, LLCAtlantaGeorgiaמגייס
DelRicht Clinical Research - AtlantaAtlantaGeorgiaמגייס
Elite Clinical Trials-IdahoBlackfootIdahoמגייס
Treasure Valley Medical ResearchBoiseIdahoמגייס
Accellacare of BristolBristolTennesseeמגייס
NY ScientificBrooklynNew Yorkמגייס
Hope Clinical Research - Canoga ParkCanoga ParkCaliforniaמגייס
Accellacare of CaryCaryNorth Carolinaמגייס
Arizona Liver Health - ChandlerChandlerArizonaמגייס
DelRicht Clinical Research - CharlestonCharlestonSouth Carolinaמגייס
Delricht Clinical Research - BadmusCharlotteNorth Carolinaמגייס
Charlottesville Medical Research Center, LLCCharlottesvilleVirginiaמגייס
Erick H. Alayo Medical CorporationChula VistaCaliforniaמגייס
GW Research Inc.Chula VistaCaliforniaמגייס
Cleveland ClinicClevelandOhioמגייס
Gastrointestinal Associates LLPColumbia FallsMontanaמגייס
Centricity Research Columbus Ohio MultispecialtyColumbusOhioמגייס
Remington Davis, Inc.ColumbusOhioמגייס
Zenos Clinical ResearchDallasTexasמגייס
EPIC Medical ResearchDeSotoTexasמגייס
Advanced Research Institute - DenverDenverColoradoמגייס
3A ResearchEl PasoTexasמגייס
Lillestol Research, LLCFargoNorth Dakotaמגייס
Coastal Research Institute, LLCFayettevilleNorth Carolinaמגייס
G & L Research, LLCFoleyAlabamaמגייס
Proactive Clinical ResearchFort LauderdaleFloridaמגייס
Woodholme GastroenterologyGlen BurnieMarylandמגייס
GI Alliance - Glenview, ILGlenviewIllinoisמגייס
DelRicht Clinical Research - GulfportGulfportMississippiמגייס
Clinical Investigation Specialists, IncGurneeIllinoisמגייס
Drug Trials AmericaHartsdaleNew Yorkמגייס
DelRicht Clinical Research - NashvilleHendersonvilleTennesseeמגייס
Peters Medical ResearchHigh PointNorth Carolinaמגייס
Tandem Clinical Research GI - HoumaHoumaLouisianaמגייס
Hometown Urgent Care and Research - Huber HeightsHuber HeightsOhioמגייס
DelRicht Clinical Research - IndianapolisIndianapolisIndianaמגייס
310 Clinical ResearchInglewoodCaliforniaמגייס
Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonJacksonNew Jerseyמגייס
Kansas City Research InstituteKansas CityMissouriמגייס
Accellacare of KnoxvilleKnoxvilleTennesseeמגייס
New Phase Research & Development - KnoxvilleKnoxvilleTennesseeמגייס
Rocky Mountain Gastroenterology (RMG) - LittletonLakewoodColoradoמגייס
Om Research LLCLancasterCaliforniaמגייס
Jubilee Clinical Research, Inc.Las VegasNevadaמגייס
Excel Clinical ResearchLas VegasNevadaמגייס
Digestive Disease SpecialistsLas VegasNevadaמגייס
Clinical Trials ResearchLincolnCaliforniaמגייס
Tekton Research - Longmont, COLongmontColoradoמגייס

59 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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