OsteoarthritisPhase 2NCT01102660
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
A Phase 2 study testing PH-797804, Naproxen and Naproxen + PH-797804 in people with Osteoarthritis, run by Pfizer at 26 sites in United States.
Trial summary
PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PH-797804, Naproxen and Naproxen + PH-797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 26 sitesUnited States
- Study dates
- May 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
- Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.
Who cannot join
- History of diseases other than osteoarthritis that may involve the index knee.
- Other severe pain that impairs the assessment of osteoarthritis of pain.
- Electrocardiogram abnormalities.
- History of gastrointestinal disorders.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Daytona Beach, Florida, 32117
Pfizer Investigational Site
Fall River, Massachusetts, 02721
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Hyannis, Massachusetts, 02601
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
New Bedford, Massachusetts, 02740
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Plantation, Florida, 33317
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Spring Valley, California, 91978
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Valley Village, California, 91607
Pfizer Investigational Site
Wichita, Kansas, 67206
Pfizer Investigational Site
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee
PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.
- Conditions
- Osteoarthritis
- Being tested
- PH-797804, Placebo, Naproxen, Naproxen + PH-797804
- Keywords
- Knee osteoarthritis, clinical trial, cross-over
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-797804Drug
Tablet, 6 mg once daily for 2 weeks
PlaceboDrug
Tablet, 0 mg once daily for 2 weeks
PlaceboDrug
Tablet, 0 mg once daily for 2 weeks
PH-797804Drug
Tablet, 6 mg once daily for 2 weeks
NaproxenDrug
Tablet, 500 mg twice daily for 2 weeks
Naproxen + PH-797804Drug
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Naproxen + PH-797804Drug
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
NaproxenDrug
Tablet, 500 mg twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Other | Not described Receives: Drug: PH-797804; Drug: Placebo |
| Treatment Sequence 2 | Other | Not described Receives: Drug: Placebo; Drug: PH-797804 |
| Treatment Sequence 3 | Other | Not described Receives: Drug: Naproxen; Drug: Naproxen + PH-797804 |
| Treatment Sequence 4 | Other | Not described Receives: Drug: Naproxen + PH-797804; Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario & McMaster Osteoarthritis Index Pain Score
Measured: 2 weeks
Secondary outcomes (4)
Western Ontario & McMaster Osteoarthritis Index Stiffness Score
Measured: 2 weeks
Western Ontario & McMaster Osteoarthritis Index Physical Function Score
Measured: 2 weeks
Western Ontario & McMaster Osteoarthritis Index Total Score
Measured: 2 weeks
Daily Pain Rating Scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102660
- Sponsor's protocol ID
- A6631026
- Status last verified
- Aug 2014
- First submitted
- 12 Apr 2010
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee
- ClinicalTrials.gov ID
- NCT01102660
- Acronym / sponsor ID
- A6631026
- Conditions
- Osteoarthritis
- Keywords
- Knee osteoarthritis, clinical trial, cross-over
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Other | Drug: PH-797804, Drug: Placebo |
| Treatment Sequence 2 | Other | Drug: Placebo, Drug: PH-797804 |
| Treatment Sequence 3 | Other | Drug: Naproxen, Drug: Naproxen + PH-797804 |
| Treatment Sequence 4 | Other | Drug: Naproxen + PH-797804, Drug: Naproxen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
- Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.
Key exclusion criteria (4 listed)
- History of diseases other than osteoarthritis that may involve the index knee.
- Other severe pain that impairs the assessment of osteoarthritis of pain.
- Electrocardiogram abnormalities.
- History of gastrointestinal disorders.
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 |
|---|---|---|
| PH-797804Tablet, 6 mg once daily for 2 weeks | Drug | Treatment Sequence 1 |
| PlaceboTablet, 0 mg once daily for 2 weeks | Drug | Treatment Sequence 1 |
| PlaceboTablet, 0 mg once daily for 2 weeks | Drug | Treatment Sequence 2 |
| PH-797804Tablet, 6 mg once daily for 2 weeks | Drug | Treatment Sequence 2 |
| NaproxenTablet, 500 mg twice daily for 2 weeks | Drug | Treatment Sequence 3 |
| Naproxen + PH-797804Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks | Drug | Treatment Sequence 3 |
| Naproxen + PH-797804Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks | Drug | Treatment Sequence 4 |
| NaproxenTablet, 500 mg twice daily for 2 weeks | Drug | Treatment Sequence 4 |
Primary outcome
Western Ontario & McMaster Osteoarthritis Index Pain Score
Time frame: 2 weeks
4 secondary outcomes
Western Ontario & McMaster Osteoarthritis Index Stiffness Score
Time frame: 2 weeks
Western Ontario & McMaster Osteoarthritis Index Physical Function Score
Time frame: 2 weeks
Western Ontario & McMaster Osteoarthritis Index Total Score
Time frame: 2 weeks
Daily Pain Rating Scale
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Pfizer CT.gov Call Center study director
Pfizer
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH-797804, Naproxen and Naproxen + PH-797804 in people with Osteoarthritis, run by Pfizer at 26 sites in United States.
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 2 inclusion and 4 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Western Ontario & McMaster Osteoarthritis Index Pain Score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2014.