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A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01554579
First received: March 12, 2012
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: September 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Osteoarthritis of the Knee
Interventions: Drug: Gefapixant
Drug: Sugar Pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sugar Pill Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
Gefapixant Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.

Participant Flow:   Overall Study
    Sugar Pill   Gefapixant
STARTED   86   85 
COMPLETED   76   58 
NOT COMPLETED   10   27 
Adverse Event                6                25 
Lack of Efficacy                2                1 
Withdrawal by Subject                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sugar Pill Sugar Pill: Placebo
Gefapixant Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Gefapixant   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   85   171 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      64  74.4%      65  76.5%      129  75.4% 
>=65 years      22  25.6%      20  23.5%      42  24.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      52  60.5%      57  67.1%      109  63.7% 
Male      34  39.5%      28  32.9%      62  36.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   1.2%      1   0.6% 
Asian      2   2.3%      2   2.4%      4   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      21  24.4%      20  23.5%      41  24.0% 
White      62  72.1%      62  72.9%      124  72.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.2%      0   0.0%      1   0.6% 
Region of Enrollment 
[Units: Participants]
     
United States   86   85   171 
Numeric Pain Rating Scale (NPRS) [1] 
[Units: Units on a scale]
Mean (Full Range)
 6.7 
 (5 to 9) 
 6.8 
 (5 to 9) 
 6.75 
 (5 to 9) 
[1] Subjects were instructed to select a number between 0 and 10 where 0 is no pain and 10 is the worst possible pain. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime.


  Outcome Measures
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1.  Primary:   The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)   [ Time Frame: 2 Weeks ]

2.  Secondary:   WOMAC Scores   [ Time Frame: 4 Weeks ]

3.  Secondary:   SF-36   [ Time Frame: 4 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development
Organization: Afferent Pharmaceuticals
phone: 650-286-1276
e-mail: info@afferentpharma.com



Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01554579     History of Changes
Other Study ID Numbers: 7264-004
AF219004 ( Other Identifier: Afferent Pharmaceuticals )
Study First Received: March 12, 2012
Results First Received: September 23, 2016
Last Updated: April 14, 2017