Chronic pain in patients with Osteo-arthritis. MedDRA version: 12.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Product Name: PF-04191834
Product Code: PF-04191834
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form
Sponsors
Pfizer Inc.235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female subjects between the ages of 18 and 75 years inclusive at the time of entering the study. 3. Diagnosis of OA of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of =229 with symptom duration for at least 3 months. X-rays taken within the last 12 months may be used for confirmation provided appropriate documentation is available. 4. Willing and able to discontinue all current analgesic therapy, including OTC pain medications and topical analgesics for OA pain, for period beginning at washout phase and continuing for the entire duration of study. 5. For subjects discontinuing background NSAIDs and COX-2 inhibitors only, an increase in NRS =1 during the placebo run-in prior to randomization at Visit 3. 6. Daily pain score =4 during the run-in in the last 3 daily diary assessments prior to randomization. 7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Body mass index (BMI) of >39 kg/m2. A BMI upper limit of 39.5 kg/m2 may be rounded down to 39.0 kg/m2 and will be acceptable for inclusion. 2. Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN (except those with a documented history of Gilbert’s Syndrome). Subjects with AST/ALT/total bilitubin >ULN and 100 or 210 msec, complete left or right bundle branch block or other clinically significant conduction abnormality, evidence of prior myocardial infarction, evidence of QTc prolongation (defined as >450 msec) or history of QTc prolongation, or any other clinically relevant abnormality on screening ECG. - If QTc is prolonged with the singlet measurement, the ECG should be repeated two more times and the average QTc of all three readings should be used to qualify the subject. 16. Known or previously exhibited hypersensitivity to the active substance naproxen (including naproxen sodium) or any of the excipients. 17. Any history of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs (ie, complete or partial syndrome of ASA-intolerancerhinosinusitis, urticaria/angioedema, nasal polyps, asthma). 18. Use of prohibited medications as listed below, in the absence of appro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of PF-04191834 versus placebo in relieving pain in patients with osteoarthritis of the knee. - To evaluate the efficacy of PF-04191834 plus naproxen versus naproxen in relieving pain in patients with osteoarthritis of the knee. - To evaluate the safety and tolerability of PF-04191834 (as monotherapy) in patients with osteoarthritis. - To evaluate the safety and tolerability of PF-04191834 when co-administered with naproxen in patients with osteoarthritis.;Secondary Objective: - To examine the pharmacokinetics of PF-04191834 in patients with osteoarthritis. - To explore the relationship between urinary LTE4 levels as a biomarker of 5-LO inhibition and efficacy of PF-04191834 in patients with osteoarthritis. - To provide samples for exploratory research into the mechanism of action of PF-04191834 and/or the disease (OA) under study.;Primary end point(s): Western Ontario & McMaster (WOMAC) Osteoarthritis Index (48 hour recall, categorical version) Pain Score (Likert Scale, Range 0-20) in the more painful knee joint as identified at screening at the end of treatment period relative to baseline as follows: PF-04191834 compared to placebo. PF-04191834 + naproxen compared to naproxen. | — |
Countries
Sweden
Outcome results
None listed