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

Constipation Predominant Irritable Bowel Syndrome Clinical Trial

— T3MPO-3  

Official title:

An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727751
• Other study ID #: TEN-01-303
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2020
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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• Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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

Related Conditions & MeSH terms

• Constipation
• Constipation Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Tenapanor

Locations

Country	Name	City	State
United States	Ardelyx Clinical Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events in >2% Patients	Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams	52-55 weeks