A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
NCT ID: NCT02993822
Last Updated: 2022-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
315 participants
INTERVENTIONAL
2017-05-22
2019-01-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Orvepitant 10mg
Orvepitant 10mg tablet, once daily for 12 weeks
Orvepitant Maleate
Tablet, once daily, oral
Orvepitant 20mg
Orvepitant 20mg tablet, once daily for 12 weeks
Orvepitant Maleate
Tablet, once daily, oral
Orvepitant 30mg
Orvepitant 30mg tablet, once daily for 12 weeks
Orvepitant Maleate
Tablet, once daily, oral
Placebo
Placebo to match tablet, once daily for 12 weeks
Placebo
Tablet, once daily, oral
Interventions
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Orvepitant Maleate
Tablet, once daily, oral
Placebo
Tablet, once daily, oral
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
* An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.
Exclusion Criteria
* Current smokers or ex-smokers with \<6 months' abstinence or cumulative history of \>10 pack years
* Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
* FEV1 \<80% predicted, measured at screening using spirometry
* History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
* Any clinically significant abnormal laboratory test result(s)
* Inability to comply with the use of prohibited and allowed medications as described in the protocol.
18 Years
ALL
No
Sponsors
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Nerre Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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Study Site 15
Chandler, Arizona, United States
Study Site 43
Los Angeles, California, United States
Study Site 52
Mission Viejo, California, United States
Study Site 20
San Diego, California, United States
Study Site 28
San Jose, California, United States
Study Site 25
Centennial, Colorado, United States
Study Site 36
Colorado Springs, Colorado, United States
Study Site 48
Waterbury, Connecticut, United States
Study Site 68
Clearwater, Florida, United States
Study Site 59
Jacksonville, Florida, United States
Study Site 12
Largo, Florida, United States
Study Site 62
Miami, Florida, United States
Study Site 57
Miami, Florida, United States
Study Site 33
Tampa, Florida, United States
Study Site 11
Winter Park, Florida, United States
Study Site 60
Meridian, Idaho, United States
Study Site 39
Normal, Illinois, United States
Study Site 34
Baltimore, Maryland, United States
Study Site 42
Edina, Minnesota, United States
Study Site 41
Minneapolis, Minnesota, United States
Study Site 37
Rochester, Minnesota, United States
Study Site 27
Missoula, Montana, United States
Study Site 16
Las Vegas, Nevada, United States
Study Site 32
Rochester, New York, United States
Study Site 55
Charlotte, North Carolina, United States
Study Site 24
Charlotte, North Carolina, United States
Study Site 53
Charlotte, North Carolina, United States
Study Site 50
Gastonia, North Carolina, United States
Study Site 54
Greensboro, North Carolina, United States
Study Site 73
Mooresville, North Carolina, United States
Study Site 71
Raleigh, North Carolina, United States
Study Site 56
Cincinnati, Ohio, United States
Study Site 74
Oklahoma City, Oklahoma, United States
Study Site 26
Tulsa, Oklahoma, United States
Study Site 38
East Providence, Rhode Island, United States
Study Site 21
Charleston, South Carolina, United States
Study Site 72
Charleston, South Carolina, United States
Study Site 22
Dallas, Texas, United States
Study Site 35
Dallas, Texas, United States
Study Site 10
Houston, Texas, United States
Study Site 49
San Antonio, Texas, United States
Study Site 23
Waco, Texas, United States
Study Site 58
Salt Lake City, Utah, United States
Study Site 19
Charlottesville, Virginia, United States
Study Site 14
Bellingham, Washington, United States
Study Site 13
Greenfield, Wisconsin, United States
Study Site 66
Niagara Falls, Ontario, Canada
Study Site 65
Québec, Quebec, Canada
Study Site 64
Trois-Rivières, Quebec, Canada
Study Site 29
Romford, Essex, United Kingdom
Study Site 94
Blackpool, Lancashire, United Kingdom
Study Site 93
Prescot, Merseyside, United Kingdom
Study Site 17
Northwood, Middlesex, United Kingdom
Study Site 40
Belfast, Northern Ireland, United Kingdom
Study Site 96
Barnsley, South Yorkshire, United Kingdom
Study Site 97
Cannock, Staffordshire, United Kingdom
Study Site 95
Stockton-on-Tees, Teesside, United Kingdom
Study Site 45
Hull, , United Kingdom
Study Site 92
Leeds, , United Kingdom
Study Site 30
Leicester, , United Kingdom
Study Site 46
London, , United Kingdom
Study Site 91
Manchester, , United Kingdom
Study Site 18
Manchester, , United Kingdom
Study Site 47
Newcastle upon Tyne, , United Kingdom
Study Site 31
North Shields, , United Kingdom
Study Site44
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VOLCANO-2
Identifier Type: -
Identifier Source: org_study_id
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