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

NCT02727751 | Completed Phase 3 Results

• 1 other identifier: TEN-01-303
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

50mg BID

EXPERIMENTAL

Tenapanor, 50 mg BID (100 mg total)

Drug: Tenapanor

Interventions

Tenapanor DRUG

Also known as: RDX5791, AZD1722

50mg BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (1)

Ardelyx Clinical Site

Miami, Florida, United States

Location

Related Publications (2)

• Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.

  PMID: 37668173 DERIVED

• 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.

  PMID: 33337659 DERIVED

MeSH Terms

Interventions

tenapanor

Results Point of Contact

• Title: Chief Development Officer
• Organization: Ardelyx

drosenbaum@ardelyx.com

5107451752

Study Officials

• David P Rosenbaum, Ph.D.

  Ardelyx, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 5, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 9, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-08

Locations

US (1)