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 - OAK Study

Astellas Pharma Europe B.V.0 sites205 target enrollmentFebruary 3, 2016

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

February 3, 2016

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

•1\.CH of suicide attempt/ suicidal behavior. Suicidal ideation within last 12m or significant risk to commit suicide, judged by inv. at Scr \& rando 2\.Current or prior psychosis, major depressive disorder or other CS psychiatric disorder 3\. Current or prior CS neurologic disease: peripheral neuropathy, stroke, cognitive impairment and seizure 4\.CS musculoskeletal disorder (exception OA), CV,GI, endocrinologic (DM allowed if controlled HbA1c? 7\.1% and no peripheral neuropathy), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, dermatologic, renal \&/or other major disease judged by inv. 5\.Active malignancy or CH of malignancy (except treated nonmelanoma skin cancer) within past 5y. 6\.CH of inflammatory arthritis: rheumatoid arthritis or CH of RPOA, osteonecrosis or avascular necrosis of bone \&/or joints or other Dx that may increase risk of RPOA 7\.Findings suggestive of RPOA/increased risk for RPOA on Scr X\-ray of index or non\-index joints (central reading) 8\.CH of shoulder Sx ,CS trauma or current symptoms: pain or impaired range of motion at shoulder joint 9\.Coagulopathy, anticoagulant tt or diagnosed thrombocytopenia or functional platelet disorder 10\.CH of paracetamol intolerance or existence of medical condition or use of concomitant medication (CM) being paracetamol contraindicated 11\.Naproxen(Nx) contraindication: hypersensitivity to Nx or Nx sodium; asthma, rhinitis, nasal polyps, urticarial or allergic\-type reactions after taking aspirin or other NSAIDs; anticipated CABG during study; active or CH of peptic ulceration; active or CH of GI bleeding (exception hemorrhoids) or perforation 12\.Tramadol (TD) contraindication: TD hypersensitivity; monoamine oxidase inhibitor used within 2w prior to Scr or during Scr or BSL periods 13\.BMI\>39 kg/m2\. 14\.CS abnormality on 12\-lead ECG at Scr or BSL (v2 predose) 15\.CH of acute coronary syndrome, ischemic or hemorrhagic stroke, transient ischemic attack, coronary or peripheral revascularization procedure, HF, ischemic heart disease, unexplained syncope, cardiac arrest, CS cardiac arrhythmias, heart block (first degree heart block allowed if PR\<210msec), torsade de pointes, structural heart disease or personal/family CH of long QT syndrome 16\.Resting FR\<50or\>100bpm; SBP\>160mmHg;DBP\>90 mmHg at Scr or BSL(v2 predose). If repeat measurement meets above criteria, pt to be excluded 17\.CH of unexplained syncopal events or symptomatic orthostatic hypotension at Scr or BSL (v2 predose) 18\.According to inv. CS abnormalities in clinical chemistry, hematology or urinalysis at Scr 19\.AST, ALT,TBL\>1\.5 times ULN at Scr 20\.GFR?60mL/min/1\.73m2(MDRD calculation) at Scr 21\.Positive result for HBSLAg, anti\-HBc, anti\-HAV \[IgM], anti\-HCV or HIV 1 antibodies \&/or HIV 2 at Scr 22\.Any IP within 28 d (or 5 half\-lives of IP, whichever longer) before Scr or scheduled to receive IP other than blinded study tt during the course of study 23\. Pt previously received NGF antibodies 24\.Major Sx/orthopedic Sx within 3m before Scr or plans for surgical intervention during study 25\.Not suitable candidate for joint replacement \& unable to stop chronic NSAID use 26\.Intra\-articular corticosteroidwithin3m prior to Scr, intraarticular hyaluronic acid within6m prior to Scr or intra\-articular local anesthetic within 12m prior to Scr or any of these therapies during Scr or BSL periods 27\.Systemic corticosteroids within 30d before Scr or during Scr or BSL periods 28\. Any med. or nonmed therapy effective reducing pain of OA o