Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
NCT05185089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-11-10
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.
Conditions
Interventions
- DRUG
-
Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
- DRUG
-
Placebo tablets to match orvepitant 30mg and 10mg tablets
Sponsors & Collaborators
-
Pharm-Olam International
collaborator INDUSTRY -
Nerre Therapeutics Ltd.
lead INDUSTRY
Principal Investigators
-
Prof. S. Birring, MB ChB, MD · Department of Respiratory Medicine, King's College Hospital, London UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2024-06-05
- Completion
- 2024-06-19
- FDA Drug
- Yes
Countries
- United States
- Netherlands
- United Kingdom
Study Locations
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