Phase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of Cough

TR12

To investigate the efficacy and safety of Nalbuphine ER (NAL ER) tablets in subjects diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and evaluate it's treatment of cough in these patients. This is a two-treatment, 2-period crossover study. Subjects will be randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluated for approximately 21 days. After completion of the first phase, subjects who received NAL ER will crossover to placebo and subjects who received placebo will crossover to NAL ER to complete Treatment Period 2.

2019-08-08

2022-05-27

2022-05-27

Completed

Early phase I

42

Inclusion Criteria: 1. Individuals diagnosed with Idiopathic Pulmonary Fibrosis 2. Chronic cough \> 8 weeks. 3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening Exclusion Criteria: 1. The following conditions are excluded: 1. Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures. 2. Interstitial lung disease (ILD) known to be caused by connective tissue disease. 3. Interstitial lung disease (ILD) known to be caused by drug related toxicity. 2. Currently on continuous oxygen therapy. 3. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blinded, placebo-controlled, 2-Treatment, 2-Period Crossover Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Matching Placebo', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2023-05-25