Phase 2
Completed N=171
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT01554579 ↗Enrolled (actual)
171
Serious AEs
0.6%
Results posted
Mar 2017
Primary outcomePrimary: The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain) — 5.3; 4.9 units on a scale
Summary
The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.
The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain) |
5.3; 4.9 | — |
| SECONDARY WOMAC Scores |
40.7; 41.0 | — |
| SECONDARY SF-36 |
3.8; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women
- Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
- Men and their female partners must use two forms of birth control
- Clinical and radiographic evidence of chronic knee osteoarthritis
- An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous osteoarthritis medications
- Ambulatory
- Have provided written informed consent
Data sourced from ClinicalTrials.gov (NCT01554579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.