Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

IDEA AG

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis of the Knee

Treatments

Drug: celecoxib

Drug: Placebo

Drug: ketoprofen in Diractin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00716547

CL-033-III-03

Details and patient eligibility

About

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Full description

The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Enrollment

1,399 patients

Sex

All

Ages

46+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent signed and dated
Age > 45 years
Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

Exclusion criteria

Skin lesions or dermatological diseases in the treatment area
Directly or indirectly involved in the conduct and administration of this study
Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
Pregnancy or lactation
Residents of psychiatric wards, prisons or other state institutions
Malignancy within the past 2 years
Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
Epilepsy
Schizophrenia
Neuropathic pain and any other pain condition requiring chronic use of pain medication
Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
Peripheral arterial disease and/or cerebrovascular disease
History of stroke or myocardial infarction
Congestive Heart failure NYHA Class II-IV
History of pancreatitis or peptic ulcers;
Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
ALT or AST levels ≥ 5 times the ULN
Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study