ACTIVE OSTEOARTHRITIS OF THE KNEE
Conditions
Interventions
Product Name: PLA-695 Liquid-Filled Capsules 100 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PLA-695
CAS Number: 865200-20-0
Current Sponsor code: WAY-198695
Concentration unit: mg mill
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women 50 to 75 years of age. a) Women must be of non-childbearing potential; women 50 years, crepitus, or morning stiffness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects who have previously not been able to tolerate NSAIDs/COX-2 inhibitors, or have not had a therapeutic response to NSAIDs for OA. - History of known hypersensitivity or allergic reaction to any of the components of PLA-695, sulfonamides, 5-lipoxygenase inhibitors, LT receptor antagonists, acetaminophen/paracetamol, or COX-2 inhibitors/NSAIDs, including aspirin. - History of any surgery at the target knee, including arthroscopic interventional surgical procedure, or anticipated need for any surgery during the study. - Arthroscopy for diagnostic purposes or lavage at the target knee within 1 year of screening, or any invasive procedures anticipated during the study. - Orthopedic surgery of the lower extremities other than the target knee within 6 months of screening, or an anticipated need for such surgery during the study. - History of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis. - Grade 4 severity on the Kellgren -Lawrence Scale on the screening target knee radiograph. - Concomitant inflammatory arthropathy or other diseases or conditions that may affect joints (eg, RA or other auto-immune diseases, metabolic bone disease, psoriatic arthritis, gout, pseudogout, infection of the target knee, chondrocalcinosis in the target knee, Paget’s disease, neuropathic conditions, hemochromatosis). - History of acute trauma leading to secondary OA of the target knee. - Cancer, or a history of cancer (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before the screening visit. - Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject’s participating in the study or that may prevent the successful completion of the study, including the following: a)Cardiovascular disease: i)History of myocardial infarction. ii)History of angina pectoris. iii)Cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormality, such as ischemia. iv)History of stroke or transient ischemic attack. v)Congestive heart failure (CHF) New York Heart Association classification for CHF: Class III or IV. vi)Uncontrolled hypertension (systolic blood pressure [SBP] =140 mmHg or diastolic blood pressure [DBP] =90 mmHg).b)Poorly controlled diabetes. c)Known or suspected untreated infections with Helicobacter pylori infection. d)History of human immunodeficiency virus (HIV) infection or known risk of HIV disease. - Any clinically significant laboratory abnormality, including those listed below: a)Liver function abnormality (total bilirubin >1.5 x the upper limit of normal [ULN], aspartate aminotransferase [AST/SGOT] > 1.2 x ULN, alanine aminotransferase [ALT/SGPT] > 1.2 x ULN). b)Anemia (hemoglobin or hematocrit below the lower limit of normal). c)Thrombocytopenia or thrombocytosis (platelets 500 mg/dL (SI units:>5.65 mmol/L). g)Serum amylase or serum lipase = 1.25 x ULN.Screening laboratory tests with abnormal results may be repeated once t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish efficacy and safety of PLA-695 in subjects with active OA of the knee.;Primary end point(s): WOMAC VAS walking pain (question 1) at week 6 ;Secondary Objective: To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among number of dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA (not in Europe). | — |
Countries
Hungary, Netherlands
Outcome results
None listed