Osteoarthritis of the KneePhase 2NCT01554579

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 testing Gefapixant and Sugar Pill in people with Osteoarthritis of the Knee, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: Gefapixant and Sugar Pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 34 sitesUnited States
Study dates: 29 Mar 2012to 21 Nov 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Afferent Investigative Site
Albuquerque, New Mexico, 87102
Afferent Investigative Site
Asheville, North Carolina, 28803
Afferent Investigative Site
Atlanta, Georgia, 30329
Afferent Investigative Site
Austin, Texas, 78705
Afferent Investigative Site
Cincinnati, Ohio, 45219
Afferent Investigative Site
Clearwater, Florida, 33756
Afferent Investigative Site
Clinton, Utah, 84015
Afferent Investigative Site
Dallas, Texas, 75231
Afferent Investigative Site
Duncansville, Pennsylvania, 16635
Afferent Investigative Site
Greensboro, North Carolina, 27408
Afferent Investigative Site
Greer, South Carolina, 29650
Afferent Investigative Site
Hazelwood, Missouri, 63042
Afferent Investigative Site
Houston, Texas, 77062
Afferent Investigative Site
Kenosha, Wisconsin, 53142
Afferent Investigative Site
Medford, Oregon, 97504
Afferent Investigative Site
Mt. Pleasant, South Carolina, 29464
Afferent Investigative Site
New Bedford, Massachusetts, 02740
Afferent Investigative Site
Olive Branch, Mississippi, 38654
Afferent Investigative Site
Orlando, Florida, 32806
Afferent Investigative Site
Phoenix, Arizona, 85018
Afferent Investigative Site
Phoenix, Arizona, 85027
Afferent Investigative Site
Pinellas Park, Florida, 33781
Afferent Investigative Site
Renton, Washington, 98057
Afferent Investigative Site
Roanoke, Virginia, 24018
Afferent Investigative Site
San Antonio, Texas, 78209
Afferent Investigative Site
San Antonio, Texas, 78229
Afferent Investigative Site
San Diego, California, 92108
Afferent Investigative Site
St Louis, Missouri, 63141
Afferent Investigative Site
Toledo, Ohio, 43623
Afferent Investigative Site
Troy, Michigan, 48098
Afferent Investigative Site
Warwick, Rhode Island, 02886
Afferent Investigative Site
Watertown, Massachusetts, 02472
Afferent Investigative Site
Wichita, Kansas, 67203
Afferent Investigative Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

Read the detailed description

Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.

Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

Conditions: Osteoarthritis of the Knee
Being tested: Gefapixant, Sugar Pill
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GefapixantDrug
Also called AF-219, MK-7264
BID
Sugar PillDrug
Placebo

Study groups in NCT01554579
Study group	Role	What they receive
Sugar pill	Placebo comparator	Not described Receives: Drug: Sugar Pill
Gefapixant	Experimental	Not described Receives: Drug: Gefapixant

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
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.
Measured: 2 Weeks

Secondary outcomes (2)

WOMAC Scores
This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.
Measured: 4 Weeks
SF-36
The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.
Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201221 Nov 2013

First posted15 Mar 2012 (estimated)
Study start29 Mar 2012
Primary completion11 Nov 2013
Study completion21 Nov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01554579
Sponsor's protocol ID: 7264-004
Other IDs: AF219004
Status last verified: Jun 2019
First submitted: 12 Mar 2012
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
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Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT01554579
Acronym / sponsor ID: 7264-004
Conditions: Osteoarthritis of the Knee
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 29 Mar 2012 (actual)
Primary completion: 11 Nov 2013 (actual)
Study completion: 21 Nov 2013 (actual)
First posted: 15 Mar 2012 (estimated)
Results: Posted 1 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

Detailed description

Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sugar pill	Placebo comparator	Drug: Sugar Pill
Gefapixant	Experimental	Drug: Gefapixant

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GefapixantAlso: AF-219, MK-7264BID	Drug	Gefapixant
Sugar PillPlacebo	Drug	Sugar pill

Primary outcome

The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
Time frame: 2 Weeks
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.

2 secondary outcomes

WOMAC Scores
Time frame: 4 Weeks
SF-36
Time frame: 4 Weeks

Results and safety

Results posted to the registry on 1 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sugar Pill	86	76
Gefapixant	85	58

Primary outcome: The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)

Time frame: 2 Weeks. Mean (Full Range). Unit: units on a scale

Measure	Sugar Pill n = 82	Gefapixant n = 74
Value	5.3 (0 to 10)	4.9 (0 to 10)

Population analysed: Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugar Pill	1 of 86 (1.2%)	17 of 86 (19.8%)	Not reported
Gefapixant	0 of 85 (0%)	75 of 85 (88.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Osteoarthritis of the Knee

Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain) (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01554579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.