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A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C (T3MPO-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727751
Recruitment Status : Completed
First Posted : April 5, 2016
Results First Posted : April 24, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Study Description
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Brief Summary:
This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

Condition or disease Intervention/treatment Phase
Constipation Predominant Irritable Bowel Syndrome Drug: Tenapanor Phase 3

Detailed Description:
During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Study Start Date : March 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Experimental: 50mg BID
Tenapanor, 50 mg BID (100 mg total)
 Drug: Tenapanor
Other Names:
  • RDX5791
  • AZD1722


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events in >2% Patients [ Time Frame: 52-55 weeks ]
    Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
  • Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
  • 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

Exclusion Criteria:

  • Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
  • The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
  • Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727751


Locations
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United States, Florida
Ardelyx Clinical Site
Miami, Florida, United States
Sponsors and Collaborators
Ardelyx
Investigators
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Study Chair: David P Rosenbaum, Ph.D. Ardelyx, Inc.
  Study Documents (Full-Text)

Documents provided by Ardelyx:
Study Protocol  [PDF] January 29, 2016
Statistical Analysis Plan  [PDF] March 8, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02727751    
Other Study ID Numbers: TEN-01-303
First Posted: April 5, 2016    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: September 9, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases