Phase 3Recruiting
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets (OCEAN-1)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
- Sponsor
- Trevi Therapeutics (Industry)
- Enrolment
- 306 planned
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- NAL ER; Placebo
- Ages
- adults, older adults
- Registry
- NCT07671911, CTIS2026-525877-38-00
Full record on ClinicalTrials.gov
From the registry
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
Primary outcomes
- Relative Change from Baseline in 24-hour Cough Frequency at Week 26
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered