A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Conditions

• Chronic Idiopathic Constipation (CIC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor 5 mg BID — DRUG
  Patients will receive tenapanor 5 mg BID (total of 10 mg daily)
• Tenapanor 25 mg BID — DRUG
  Patients will receive tenapanor 25 mg BID (total of 50 mg daily)
• Tenapanor 50 mg BID — DRUG
  Patients will receive tenapanor 50 mg BID (total of 100 mg daily)
• Placebo — DRUG
  Patients will receive matching placebo BID

Study Details

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.

Key Dates

Start date

Jan 13, 2026

Status verified

Jun 2026

Primary completion

Feb 26, 2027

Completion

Jun 4, 2027

Study Design

Enrollment

692 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tenapanor 5 mg BID
  Patients will be randomized to receive 5 mg tenapanor twice daily.
• Experimental: Tenapanor 25 mg BID
  Patients will be randomized to receive 25 mg tenapanor twice daily.
• Experimental: Tenapanor 50 mg BID
  Patients will be randomized to receive 50 mg tenapanor twice daily.
• Placebo Comparator: Placebo Comparator
  Patients will be randomized to receive matching placebo twice daily.

Primary Outcome Measure

Durable complete spontaneous bowel movements (CSBM) response [ Time Frame: 12 Weeks ]

Central Contacts

• Marica Tambongco
  (617) 875-7968
  [email protected]

Locations (109)

Find similar trials in Foley, AL

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