Overview

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

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IDEA AG
Treatments:
Celecoxib
Ketoprofen
Criteria
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