Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2015-12-17
2016-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gefapixant 15 mg twice daily
Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant
Gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant 30 mg twice daily
Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant
Gefapixant tablets administered by mouth twice daily for 8 weeks
Gefapixant 50 mg twice daily
One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Gefapixant
Gefapixant tablets administered by mouth twice daily for 8 weeks
Placebo to match gefapixant
Matching placebo tablets administered by mouth twice daily for 8 weeks
Placebo (for gefapixant)
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Interventions
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Gefapixant
Gefapixant tablets administered by mouth twice daily for 8 weeks
Placebo (for gefapixant)
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have refractory chronic cough
* Women of child-bearing potential must use 2 forms of acceptable birth control
* Have provided written informed consent.
* Are willing and able to comply with all aspects of the protocol.
Exclusion Criteria
* Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) \< 60%
* History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
* History of opioid use within 1 week of the Baseline Visit
* Body mass index (BMI) \<18 kg/m2 or ≥ 40 kg/m2
* History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with \<3 excised basal cell carcinomas)
* Screening systolic blood pressure (SBP) \>160 mm Hg or a diastolic blood pressure (DBP) \>90 mm Hg
* Significantly abnormal laboratory tests at Screening
* Clinically significant abnormal electrocardiogram (ECG)
* Pregnant or Breastfeeding
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
18 Years
80 Years
ALL
No
Sponsors
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Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Afferent Investigative Site
Mission Viejo, California, United States
Afferent Investigative Site
San Jose, California, United States
Afferent Investigative Site
Colorado Springs, Colorado, United States
Afferent Investigative Site
Largo, Florida, United States
Afferent Investigative Site
Charlotte, North Carolina, United States
Afferent Investigative Site
Tulsa, Oklahoma, United States
Afferent Investigative Site
Dallas, Texas, United States
Afferent Investigative Site
San Antonio, Texas, United States
Afferent Investigative Site
Bellevue, Washington, United States
Afferent Investigative Site
Greenfield, Wisconsin, United States
Countries
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Other Identifiers
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AF219-021
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7264-021
Identifier Type: OTHER
Identifier Source: secondary_id
7264-021
Identifier Type: -
Identifier Source: org_study_id
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