At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
NAL ER +1 moredrug
Likely dose
NAL ER 27 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 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
In Brief
A Phase 2 clinical trial evaluating NAL ER and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 42 participants across 11 sites.
Detailed Summary
To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesUnited Kingdom
CollaboratorsParexel
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartOct 2019
Primary CompletionMay 2022
TodayJul 2026
First PostedJul 23, 2019
Enrollment StartOct 29, 2019
Primary CompletionMay 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.9 years ago
Interventions
NAL ERdrug
Participants received NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID.
Placebodrug
Participants received Placebo tablet (matching NAL ER ).