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

RecruitingPhase 3Ages 40 Years - anyAllTrevi Therapeutics
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines. * Chronic cough for โ‰ฅ8 weeks prior to Screening. * PGI-Severity Score โ‰ฅ 2 at Screening. * Forced vital capacity (FVC) โ‰ฅ40 percent (%) of predicted at Screening. * Diffusing capacity for carbon monoxide (DLCO) โ‰ฅ25% of predicted during Screening or within 12 weeks prior to Screening. * Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit. Exclusion Criteria: * Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening. * Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.
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What it tests

  • NAL ER
  • Placebo
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Where

22 sites
Newportnativemd, Inc.
Newport Beach, United States
Palmtree Clinical Research
Palm Springs, United States
Paradigm Clinical Research Centers, Inc. - Redding
Redding, United States
Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic
Lakewood, United States
Meris Clinical Research
Brandon, United States
Clinical Research Specialists, Llc - Kissimmee
Kissimmee, United States
Pulmonary Specialists of The Palm Beaches
Loxahatchee Groves, United States
Clinical Research and Associates, Inc.
Miami, United States

โ€ฆand 14 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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