Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

IDEA AG

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: ketoprofen in Diractin®; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722852

CL-033-III-06

Details and patient eligibility

About

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

Full description

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

Enrollment: 555 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 and to ingredients of the IMP
• Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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555 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ketoprofen in Diractin®

2

Placebo Comparator group

Treatment:

Drug: Placebo