NCT02993822

A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Nerre Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

Detailed description

A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC). Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups. Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total). All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.

Conditions

• Chronic Refractory Cough

Interventions

Type	Name	Description
DRUG	Orvepitant Maleate	Tablet, once daily, oral
DRUG	Placebo	Tablet, once daily, oral

Timeline

• Start date: 2017-05-22
• Primary completion: 2019-01-14
• Completion: 2019-01-24
• First posted: 2016-12-15
• Last updated: 2022-04-26
• Results posted: 2022-04-26

Locations

66 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study