A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Phase 3

Completed

• Conditions: Constipation Predominant Irritable Bowel Syndrome
• Interventions: Drug: Tenapanor

• Registration Number: NCT02727751
• Lead Sponsor: Ardelyx

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2020-04-10
• Results First Submitted QC: 2020-04-10
• Results First Posted: 2020-04-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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• Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50mg BID	Tenapanor	Tenapanor, 50 mg BID (100 mg total)

Primary Outcome Measures

Name	Time	Method
Adverse Events in >2% Patients	52-55 weeks	Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams

Trial Locations

Locations (1)

Ardelyx Clinical Site; 🇺🇸 Miami, Florida, United States