A 26-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults

Summary

This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.

Description

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Tenapanor 5 mg BID

  Patients will receive tenapanor 5 mg BID (total of 10 mg daily)

• Drug
  Tenapanor 25 mg BID

  Patients will receive tenapanor 25 mg BID (total of 50 mg daily)

• Drug
  Tenapanor 50 mg BID

  Patients will receive tenapanor 50 mg BID (total of 100 mg daily)

• Drug
  Placebo

  Patients will receive matching placebo BID

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