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A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2)

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ClinicalTrials.gov Identifier: NCT02686138
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : April 13, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE February 19, 2016
Results First Submitted Date  ICMJE March 30, 2020
Results First Posted Date  ICMJE April 13, 2020
Last Update Posted Date April 22, 2020
Study Start Date  ICMJE December 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2016)
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
    An overall CSBM responder is defined as a weekly responder for the first 6/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
  • Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
    An overall abdominal pain responder is defined as a weekly responder for the first 6/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
  • Percentage of Subjects With Overall Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
    An overall responder is defined as a weekly responder for the first 13/26 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
    An overall CSBM responder is defined as a weekly responder for the first 13/26 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
  • Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
    An overall abdominal pain responder is defined as a weekly responder for the first 13/26 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
  • Percentage of Subjects With Overall Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
    An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
    An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
  • Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
    An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2016)
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
  • Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]
  • Percentage of Subjects With Overall Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
  • Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks [ Time Frame: 26 weeks ]
  • Percentage of Subjects With Overall Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
  • Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
  • Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks [ Time Frame: First 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
Official Title  ICMJE A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Brief Summary This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of Tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for a 26 week treatment period.
Detailed Description During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation Predominant Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Tenapanor
    Other Names:
    • RDX5791
    • AZD1722
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 50mg BID
    Tenapanor, 50mg BID (100mg total)
    Intervention: Drug: Tenapanor
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2020 Dec 12;Publish Ahead of Print. doi: 10.14309/ajg.0000000000001056. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
593
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2016)
600
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females aged 18 to 75 years, inclusive
  • Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
  • Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
  • Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
  • A colonoscopy based on AGA guidelines; every 10 years at ≥50 years old

Exclusion Criteria:

  • Functional diarrhea as defined by Rome III criteria
  • IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
  • Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome.
  • Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
  • Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
  • Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine >2 mg/dL)
  • Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
  • Any surgery on the stomach, small intestine or colon, excluding appendectomy and cholecystectomy (unless within 60 days of screening visit)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02686138
Other Study ID Numbers  ICMJE TEN-01-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ardelyx
Study Sponsor  ICMJE Ardelyx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: David P Rosenbaum, Ph.D. Ardelyx, Inc.
PRS Account Ardelyx
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP