OsteoarthritisPhase 2NCT00483977
A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee
A Phase 2 study testing Oxycodone and PF-000592379 in people with Osteoarthritis, run by Pfizer at 21 sites in United States.
Trial summary
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Oxycodone and PF-000592379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2007to Dec 2007
- 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 of any race
- Between the ages of 18 and 75 years
- Knee Pain due to osteoarthritis
Who cannot join
- Pregnant
- Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
- History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Pfizer Investigational Site
Boca Raton, Florida, 33486
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Durham, North Carolina, 27704
Pfizer Investigational Site
Fair Oaks, California, 95628
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Longwood, Florida, 32779
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Miami, Florida, 33186
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
Orangevale, California, 95662
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tucson, Arizona, 85741
About this study
Official title: A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
- Conditions
- Osteoarthritis
- Being tested
- Oxycodone, Placebo, PF-000592379
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
PlaceboDrug
Placebo: oral for 2 weeks.
PF-000592379Drug
PF-00592379: oral, 30 mg, once a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | Not described Receives: Drug: Oxycodone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PF-00592379 | Experimental | Not described Receives: Drug: PF-000592379 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the pain score averaged over the last week of treatment
Measured: 2 weeks
Secondary outcomes (4)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
Measured: 2 weeks
Patient Global Impression of Change
Measured: 2 weeks
Patients Global Assessment of Osteoarthritis
Measured: 2 weeks
Pharmacokinetic trough levels
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 posted8 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Met criteria for study futility at interim analysis
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483977
- Sponsor's protocol ID
- A7771010
- Status last verified
- Apr 2011
- First submitted
- 6 Jun 2007
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis
- ClinicalTrials.gov ID
- NCT00483977
- Acronym / sponsor ID
- A7771010
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Met criteria for study futility at interim analysis
- Enrolment
- 113 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Jun 2007 (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.
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Drug: Oxycodone |
| Placebo | Placebo comparator | Drug: Placebo |
| PF-00592379 | Experimental | Drug: PF-000592379 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female of any race
- Between the ages of 18 and 75 years
- Knee Pain due to osteoarthritis
Key exclusion criteria (3 listed)
- Pregnant
- Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
- History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
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 |
|---|---|---|
| OxycodoneOxycodone: oral controlled release, 20 mg, twice a day for 2 weeks | Drug | Oxycodone |
| PlaceboPlacebo: oral for 2 weeks. | Drug | Placebo |
| PF-000592379PF-00592379: oral, 30 mg, once a day for 2 weeks | Drug | PF-00592379 |
Primary outcome
Change from baseline in the pain score averaged over the last week of treatment
Time frame: 2 weeks
4 secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
Time frame: 2 weeks
Patient Global Impression of Change
Time frame: 2 weeks
Patients Global Assessment of Osteoarthritis
Time frame: 2 weeks
Pharmacokinetic trough levels
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Met criteria for study futility at interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
21 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 Oxycodone and PF-000592379 in people with Osteoarthritis, run by Pfizer at 21 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The study was stopped early (reason given: Met criteria for study futility at interim analysis). Results are not available in the source record.
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?
Change from baseline in the pain score averaged over the last week of treatment (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 29 Apr 2011.