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See termination reason in detailed description.
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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, particularly to test if patients have less pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04191834 followed by placebo | Experimental | PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo. |
|
| Placebo followed by PF-04191834 | Experimental | Placebo followed by 600 mg BID dose of PF-04191834 plus 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 |
|
| Naproxen followed by PF-04191834+Naproxen | Experimental | Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04191834 | Drug | 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Peoria | Arizona | 85381 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04191834 Followed by Placebo | PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks. |
| FG001 | Placebo Followed by PF-04191834 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| PF-04191834 placebo | Drug | Matching PF-04191834 placebo tablets to be administered BID for two weeks |
|
| Naproxen placebo | Drug | Matching naproxen placebo tablets to be administered BID for 4 weeks |
|
| PF-04191834 placebo | Drug | Matching PF-04191834 placebo tablets to be administered BID for two weeks |
|
| PF-04191834 | Drug | 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks |
|
| Naproxen placebo | Drug | Matching naproxen placebo tablets to be administered BID for 4 weeks |
|
| PF-04191834 | Drug | 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks |
|
| Naproxen | Drug | Naproxen 500 mg tablet administered BID for a total of four weeks |
|
| PF-04191834 placebo | Drug | Matching PF-04191834 placebo tablets to be administered BID for two weeks |
|
| Naproxen | Drug | Naproxen 500 mg tablet administered BID for a total of four weeks |
|
| PF-04191834 placebo | Drug | Matching PF-04191834 placebo tablets to be administered BID for two weeks |
|
| PF-04191834 | Drug | 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks |
|
| 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. | 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. | 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. | 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). | 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). | 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. | Day -7 (Visit 2) up to 28-day follow-up (Visit 10) |
| Plasma Concentration of PF-04191834 | 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. | Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85015 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Carmichael | California | 95608 | United States |
| Pfizer Investigational Site | Fair Oaks | California | 95628 | United States |
| Pfizer Investigational Site | San Diego | California | 92128 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80209 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | South Bend | Indiana | 46601 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01610 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55114 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89144 | United States |
| Pfizer Investigational Site | Monroe | North Carolina | 28112 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43213 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22205 | United States |
| Pfizer Investigational Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 3M7 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Stockholm | 115 22 | Sweden |
PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks. |
| FG002 | PF-04191834 + Naproxen Followed by Naproxen | PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks. |
| FG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Period of 2 Weeks |
|
| Second Intervention |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5) |
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| Primary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | 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. | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | 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). | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits |
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| Secondary | 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). | Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | 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. | Number of subjects analyzed (N) is the number of participants taking rescue mediation. | Posted | Mean | Standard Deviation | Number of pills | Day -7 (Visit 2) up to 28-day follow-up (Visit 10) |
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| Secondary | Plasma Concentration of PF-04191834 | Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43 |
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| Secondary | 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. | Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable. | Posted | Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04191834 | PF-04191834 600 mg BID administered either in Period 1 or Period 2 | 0 | 79 | 35 | 79 | ||
| EG001 | Placebo | Placebo administered either in Period 1 or Period 2 | 1 | 81 | 43 | 81 | ||
| EG002 | PF-04191834 + Naproxen | PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2 | 2 | 81 | 39 | 81 | ||
| EG003 | Naproxen | Naproxen 500 mg BID administered either in Period 1 or Period 2 | 0 | 83 | 42 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Nodal arrhythmia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Conjuctivitis | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Eye penetration | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| ECG signs of myocardial ischaemia | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Heart sounds abnormal | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Arthritis | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Bursitis | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hemicephalalgia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Other |
|
| Change from Baseline |
|
The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates. |
| ANCOVA |
| 0.701 |
| Mean Difference (Net) |
| -0.20 |
| Standard Error of the Mean |
| 0.369 |
| 2-Sided |
| 80 |
| -0.67 |
| 0.28 |
| No |
| Superiority or Other |
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
| OG002 |
| PF-04191834 + Naproxen Followed by Naproxen |
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks. |
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks. |
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks. |
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|
|
|
| OG003 | Naproxen Followed by PF-04191834 + Naproxen | Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks. |
|