Osteoarthritis, KneePhase 2NCT01147458

A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

A Phase 2 study testing PF-04191834 and Naproxen in people with Osteoarthritis, Knee, run by Pfizer at 31 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: PF-04191834 and Naproxen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 31 sitesin 3 countries
Study dates: Jul 2010to Feb 2011
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
Subjects must be willing and able to stop all current pain therapy for the duration of the study
Subjects must be willing and able to complete a daily diary

Who cannot join

BMI of >39 kg/m2
Known allergy or hypersensitivity to naproxen
Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments

Trial locations and contacts

31 sites in 3 countries.

Country

City, postcode or hospital

31 sites in 3 countries

United States25 sites

Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Fair Oaks, California, 95628
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Las Vegas, Nevada, 89144
Pfizer Investigational Site
Monroe, North Carolina, 28112
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Phoenix, Arizona, 85015
Pfizer Investigational Site
Saint Paul, Minnesota, 55114
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Worcester, Massachusetts, 01610

Other trials in United States

Canada4 sites

Pfizer Investigational Site
Québec, Quebec, G1V 3M7
Pfizer Investigational Site
Québec, Quebec, G1W 4R4
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5

Other trials in Canada

Sweden2 sites

Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Stockholm, 115 22

Other trials in Sweden

About this study

Official title: A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor PF-04191834 Alone And In Combination With Naproxen In Patients With Flare-Enriched Osteoarthritis Of The Knee

Read the detailed description

This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Conditions: Osteoarthritis, Knee
Being tested: PF-04191834, PF-04191834 placebo, Naproxen placebo, Naproxen
Keywords: Cross-over, safety, efficacy, tolerability, osteoarthritis, knee, pain
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis, Pain

What participants receive

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

PF-04191834Drug
100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
PF-04191834 placeboDrug
Matching PF-04191834 placebo tablets to be administered BID for two weeks
Naproxen placeboDrug
Matching naproxen placebo tablets to be administered BID for 4 weeks
PF-04191834 placeboDrug
Matching PF-04191834 placebo tablets to be administered BID for two weeks
PF-04191834Drug
100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
Naproxen placeboDrug
Matching naproxen placebo tablets to be administered BID for 4 weeks
PF-04191834Drug
100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
NaproxenDrug
Naproxen 500 mg tablet administered BID for a total of four weeks
PF-04191834 placeboDrug
Matching PF-04191834 placebo tablets to be administered BID for two weeks
NaproxenDrug
Naproxen 500 mg tablet administered BID for a total of four weeks
PF-04191834 placeboDrug
Matching PF-04191834 placebo tablets to be administered BID for two weeks
PF-04191834Drug
100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Study groups in NCT01147458
Study group	Role	What they receive
PF-04191834 followed by placebo	Experimental	PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo. Receives: Drug: PF-04191834; Drug: PF-04191834 placebo; Drug: Naproxen placebo
Placebo followed by PF-04191834	Experimental	Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo. Receives: Drug: PF-04191834 placebo; Drug: PF-04191834; Drug: Naproxen placebo
PF-04191834+Naproxen followed by Naproxen	Experimental	PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo Receives: Drug: PF-04191834; Drug: Naproxen; Drug: PF-04191834 placebo
Naproxen followed by PF-04191834+Naproxen	Experimental	Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID Receives: Drug: Naproxen; Drug: PF-04191834 placebo; Drug: PF-04191834

What is being measured

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

Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1
The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.
Measured: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)
Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2
The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.
Measured: Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)

Secondary outcomes (9)

WOMAC Stiffness Domain Score
The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.
Measured: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
WOMAC Physical Function Domain Score
The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.
Measured: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
WOMAC Total Score
The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.
Measured: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
Importance Weighted Total WOMAC Score
Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.
Measured: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
Daily Diary Pain Score During Week 1 of Each Treatment Period
The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).
Measured: 4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits
Daily Diary Pain Score During Week 2 of Each Treatment Period
The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).
Measured: Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2
Rescue Medication Use
Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.
Measured: Day -7 (Visit 2) up to 28-day follow-up (Visit 10)
Plasma Concentration of PF-04191834
Measured: Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43
Urinary Leukotriene E4 (LTE4) Levels
LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.
Measured: Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)

Timeline

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

Jul 2010Feb 2011

First posted22 Jun 2010 (estimated)
Study startJul 2010
Primary completionFeb 2011
Study completionFeb 2011

Why it stopped: See termination reason in detailed description.

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, KneeStudies 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: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01147458
Sponsor's protocol ID: B0041007
Status last verified: May 2013
First submitted: 16 Jun 2010
Last updated: 6 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor PF-04191834 Alone And In Combination With Naproxen In Patients With Flare-Enriched Osteoarthritis Of The Knee
ClinicalTrials.gov ID: NCT01147458
Acronym / sponsor ID: B0041007
Conditions: Osteoarthritis, Knee
Keywords: Cross-over, safety, efficacy, tolerability, osteoarthritis, knee, pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 190 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 21 May 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
PF-04191834 followed by placebo	Experimental	Drug: PF-04191834, Drug: PF-04191834 placebo, Drug: Naproxen placeboPF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.
Placebo followed by PF-04191834	Experimental	Drug: PF-04191834 placebo, Drug: PF-04191834, Drug: Naproxen placeboPlacebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.
PF-04191834+Naproxen followed by Naproxen	Experimental	Drug: PF-04191834, Drug: Naproxen, Drug: PF-04191834 placeboPF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo
Naproxen followed by PF-04191834+Naproxen	Experimental	Drug: Naproxen, Drug: PF-04191834 placebo, Drug: PF-04191834Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
Subjects must be willing and able to stop all current pain therapy for the duration of the study
Subjects must be willing and able to complete a daily diary

Key exclusion criteria (3 listed)

BMI of >39 kg/m2
Known allergy or hypersensitivity to naproxen
Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments

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
PF-04191834100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks	Drug	PF-04191834 followed by placebo
PF-04191834 placeboMatching PF-04191834 placebo tablets to be administered BID for two weeks	Drug	PF-04191834 followed by placebo
Naproxen placeboMatching naproxen placebo tablets to be administered BID for 4 weeks	Drug	PF-04191834 followed by placebo
PF-04191834 placeboMatching PF-04191834 placebo tablets to be administered BID for two weeks	Drug	Placebo followed by PF-04191834
PF-04191834100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks	Drug	Placebo followed by PF-04191834
Naproxen placeboMatching naproxen placebo tablets to be administered BID for 4 weeks	Drug	Placebo followed by PF-04191834
PF-04191834100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks	Drug	PF-04191834+Naproxen followed by Naproxen
NaproxenNaproxen 500 mg tablet administered BID for a total of four weeks	Drug	PF-04191834+Naproxen followed by Naproxen
PF-04191834 placeboMatching PF-04191834 placebo tablets to be administered BID for two weeks	Drug	PF-04191834+Naproxen followed by Naproxen
NaproxenNaproxen 500 mg tablet administered BID for a total of four weeks	Drug	Naproxen followed by PF-04191834+Naproxen
PF-04191834 placeboMatching PF-04191834 placebo tablets to be administered BID for two weeks	Drug	Naproxen followed by PF-04191834+Naproxen
PF-04191834100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks	Drug	Naproxen followed by PF-04191834+Naproxen

Primary outcome

Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1
Time frame: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)
The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.
Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2
Time frame: Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)
The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.

9 secondary outcomes

WOMAC Stiffness Domain Score
Time frame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
WOMAC Physical Function Domain Score
Time frame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
WOMAC Total Score
Time frame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
Importance Weighted Total WOMAC Score
Time frame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
Daily Diary Pain Score During Week 1 of Each Treatment Period
Time frame: 4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits
Daily Diary Pain Score During Week 2 of Each Treatment Period
Time frame: Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2
Rescue Medication Use
Time frame: Day -7 (Visit 2) up to 28-day follow-up (Visit 10)
Plasma Concentration of PF-04191834
Time frame: Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43
Urinary Leukotriene E4 (LTE4) Levels
Time frame: Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)

Results and safety

Results posted to the registry on 21 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04191834 Followed by Placebo	48	34
Placebo Followed by PF-04191834	47	31
PF-04191834 + Naproxen Followed by Naproxen	47	35
Naproxen Followed by PF-04191834 + Naproxen	48	34

Primary outcome: Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1

Time frame: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5). Mean (Standard Deviation). Unit: Units on a scale

Measure	PF-04191834 Followed by Placebo n = 48	Placebo Followed by PF-04191834 n = 47	PF-04191834 + Naproxen Followed by Naproxen n = 47	Naproxen Followed by PF-04191834 + Naproxen n = 48
Baseline	11.3 (2.34)	11.5 (2.81)	10.8 (2.60)	11.1 (2.93)
Change from Baseline	-1.2 (2.49)	-1.6 (3.10)	-1.9 (2.97)	-1.6 (2.93)

PF-04191834 Followed by Placebo vs Placebo Followed by PF-04191834: Mean Difference (Net): 0.56 (80% CI 0.08 to 1.04), p = 0.067, ANCOVA
PF-04191834 + Naproxen Followed by Naproxen vs Naproxen Followed by PF-04191834 + Naproxen: Mean Difference (Net): -0.20 (80% CI -0.67 to 0.28), p = 0.701, ANCOVA

Population analysed: Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.

Primary outcome: Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2

Time frame: Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9). Mean (Standard Deviation). Unit: Units on a scale

Measure	PF-04191834 Followed by Placebo n = 48	Placebo Followed by PF-04191834 n = 47	PF-04191834 + Naproxen Followed by Naproxen n = 47	Naproxen Followed by PF-04191834 + Naproxen n = 48
Baseline	9.7 (3.53)	8.6 (3.15)	9.7 (2.74)	10.2 (3.47)
Change from Baseline	-1.8 (2.58)	-0.6 (2.44)	-1.5 (3.64)	-2.1 (3.03)

PF-04191834 Followed by Placebo vs Placebo Followed by PF-04191834: Mean Difference (Net): 0.56 (80% CI 0.08 to 1.04), p = 0.067, ANCOVA
PF-04191834 + Naproxen Followed by Naproxen vs Naproxen Followed by PF-04191834 + Naproxen: Mean Difference (Net): -0.20 (80% CI -0.67 to 0.28), p = 0.701, ANCOVA

Population analysed: Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04191834	0 of 79 (0%)	35 of 79 (44.3%)	Not reported
Placebo	1 of 81 (1.2%)	43 of 81 (53.1%)	Not reported
PF-04191834 + Naproxen	2 of 81 (2.5%)	39 of 81 (48.1%)	Not reported
Naproxen	0 of 83 (0%)	42 of 83 (50.6%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early due to increases in hepatic enzymes for which a relationship to study drug could not be excluded and that could alter the potential benefit-risk for participants continuing in the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

31 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04191834 and Naproxen in people with Osteoarthritis, Knee, run by Pfizer at 31 sites in 3 countries.

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 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada, Sweden. 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?

Yes. Results are posted in the registry (first posted 21 May 2013). 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?

Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1 (time frame: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)). The study lists 2 primary outcomes in all. 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 NCT01147458.

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 6 Jun 2013.