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NCT01554579 · ClinicalTrials.gov registry record · Phase 2
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
A Phase 2 study, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT01554579: Completed Phase 2 study, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01554579 is a Phase 2 study that has completed, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01554579, a Phase 2 study, has completed, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study 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.
Primary Outcome
Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
Interventions
- DRUG Sugar Pill
- DRUG Gefapixant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2012-03-29 |
| Est. Completion | 2013-11-21 |
| Phase | Phase 2 |
Sponsor
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
What the finished NCT01554579 record still lists
NCT01554579 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 2 interventions - of which Sugar Pill is the first listed.
NCT01554579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01554579 about?
NCT01554579 is a clinical study titled "A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee". 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...
What is the current status of trial NCT01554579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2012-03-29. Estimated completion is 2013-11-21.
What interventions are being tested in trial NCT01554579?
The interventions under investigation include: Sugar Pill (DRUG), Gefapixant (DRUG).
Who is sponsoring clinical trial NCT01554579?
This trial is sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01554579's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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