At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
Orvepitant Maleate +1 moredrug
Likely dose
Orvepitant Maleate 30mgfrom 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 Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 2 clinical trial evaluating Orvepitant Maleate and Placebo for Cough and Idiopathic Pulmonary Fibrosis. Completed, enrolled 80 participants across 37 sites in 3 countries.
Detailed Summary
ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCough, Idiopathic Pulmonary Fibrosis
CountriesNetherlands, United Kingdom, United States
CollaboratorsPharm-Olam International
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedJan 2022
Enrollment StartAug 2022
Primary CompletionJun 2024
Study CompletionJun 2024
TodayJul 2026
First PostedJan 11, 2022
Enrollment StartAug 1, 2022
Primary CompletionJun 5, 2024
Study CompletionJun 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.5 years ago
Interventions
Orvepitant Maleatedrug
Orvepitant tablets 30mg or 10mg
Placebodrug
Placebo tablets to match orvepitant 30mg and 10mg tablets