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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02993822
Study type Interventional
Source Nerre Therapeutics Ltd.
Contact
Status Completed
Phase Phase 2
Start date May 22, 2017
Completion date January 24, 2019

See also
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Completed NCT01703923 - An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough Phase 2
Terminated NCT03979638 - A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough Phase 2