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Completed

NCT Number: NCT00722852

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

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

46 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hope Research Institute, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketoprofen in Diractin®

Drug

100 mg (b.i.d.)

Placebo

Drug

100 mg (b.i.d.)

Primary outcomes

  1. pain subscale of the WOMAC

    Time frame: week 12

Secondary outcomes

  1. Patient global assessment of response to therapy

    Time frame: week 12

  2. function subscale of the WOMAC

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

IDEA AG

Industry

Registry information

Official study title

Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 28, 2008
Registry last updated
Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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