A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥18 to ≤80 years old at the Screening visit (Visit 1). 2. Meet the Rome IV Diagnostic Criteria for functional constipation. 3. Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication. 4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization. 5. Meets the entry criteria assessed during the Screening period. 6. Ability to understand and provide input on the assessments in the eDiary. 7. Provide written informed consent before the initiation of any study-specific procedures. 8. Must agree to have daily access to eDiary via a computer, tablet or smart phone Exclusion Criteria: 1. Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit 2. Fecal impaction within 6 months prior