Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets

Study acronym: OCEAN-1
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 19 → 22 locations
    • Eligibility criteria expanded, about 8 words
  2. Trial sites expanded: 15 → 19 locations
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoints: 22 to 23
    v4
  3. Trial sites expanded: 5 → 15 locationsv3
  4. Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Jun 2026 to Jun 29, 2026
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07671911
Lead Sponsor Trevi Therapeutics
Conditions
(from sponsor)		 Idiopathic Pulmonary Fibrosis
Related terms Idiopathic Pulmonary Fibrosis
Enrollment 306 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov