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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05185089 on ClinicalTrials.gov