A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7962 in Patients with Pain Due to Osteoarthritis of the Knee

Astellas Pharma Europe B.V.0 sites205 target enrollmentDecember 14, 2015

ConditionsOsteoarthritis of the knee MedDRA version: 18.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsNAPROXEN Tablets USP

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis of the knee
Sponsor: Astellas Pharma Europe B.V.
Enrollment: 205
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 14, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Astellas Pharma Europe B.V.

Eligibility Criteria

Inclusion Criteria

•1\. Institutional Review Board (IRB)\-/Independent Ethics Committee (IEC)\-approved written Informed Consent and privacy language as per national regulations.
•2\. Patient is a male or female patient and aged 18 to 75 years, at screening.
•3\. Patient has a primary diagnosis of OA of the index knee with symptoms for at least 6 months prior to screening and patient meets American College of Rheumatology clinical classification criteria for OA of the knee, defined by the following.
•Knee pain and at least 3 of the following 6 (a\-f):
•a) Age \> 50 years
•b) Morning stiffness \< 30 minutes
•c) Crepitus on active motion
•d) Bony tenderness
•e) Bony enlargement
•f) No palpable warmth of synovium

Exclusion Criteria

•3 Current or prior clinically significant neurologic disease, including but not limited to peripheral neuropathy, stroke, cognitive impairment and seizure.
•4 Any clinically significant, musculoskeletal disorder (with the exception of OA), cardiovascular, gastrointestinal, endocrinologic (diabetes mellitus is allowed if controlled \[glycated hemoglobin (HbA1c) \= 7\.1%] and no peripheral neuropathy), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, dermatologic, renal and/or other major disease.
•6 History of inflammatory arthritis, including rheumatoid arthritis or a history of RPOA, osteonecrosis or avascular necrosis of bone and/or joints or has other diagnoses that may increase the risk of RPOA.
•7 Findings suggestive of RPOA or increased risk for RPOA on screening radiographs of either index or non\-index joints.
•8 History of shoulder surgery, clinically significant trauma or current symptoms, including pain or impaired range of motion at shoulder joint.
•9 Coagulopathy, receiving anticoagulants or diagnosed with thrombocytopenia or a functional platelet disorder.
•10 History of paracetamol intolerance, or medical condition or use of concomitant medication for which paracetamol is contraindicated.
•11 Any contraindication to naproxen
•12 Any contraindication to tramadol
•15 History of acute coronary syndrome, ischemic or hemorrhagic stroke, transient ischemic attack, coronary or peripheral revascularization procedure, heart failure, ischemic heart disease, unexplained syncope, cardiac arrest, clinically significant cardiac arrhythmias (including atrial fibrillation or flutter), heart block (first degree heart block is allowed provided PR interval is not greater than 210 msec), torsade de pointes, structural heart disease or a personal or family history of long QT syndrome.