Back to resultsA Long-Term Safety Study of Tenapanor for the Treatment of IBS-C (T3MPO-3)
Primary Purpose
Constipation Predominant Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenapanor
Sponsored by
About this trial
This is an interventional treatment trial for Constipation Predominant Irritable Bowel Syndrome
Eligibility 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- Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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
Sites / Locations
- Ardelyx Clinical Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
50mg BID
Arm Description
Tenapanor, 50 mg BID (100 mg total)
Outcomes
Primary Outcome Measures
Adverse Events in >2% Patients
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02727751
Brief Title
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Acronym
T3MPO-3
Official Title
An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation Predominant Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50mg BID
Arm Type
Experimental
Arm Description
Tenapanor, 50 mg BID (100 mg total)
Intervention Type
Drug
Intervention Name(s)
Tenapanor
Other Intervention Name(s)
RDX5791, AZD1722
Primary Outcome Measure Information:
Title
Adverse Events in >2% Patients
Description
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams
Time Frame
52-55 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Rosenbaum, Ph.D.
Organizational Affiliation
Ardelyx, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Ardelyx Clinical Site
City
Miami
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33337659
Citation
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. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.
Results Reference
derived
Learn more about this trial
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
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