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โ† Trials
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Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (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 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. * If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) 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 8 weeks 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

4 sites
Premier Medical Associates, LLC
Wilmington, United States
Essential Health and Research Services
North Miami Beach, United States
American Health Research - Charlotte Location
Charlotte, United States
Hillcroft Medical Clinic
Sugar Land, United States
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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