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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722852

Enrollment

555

Registered

2008-07-28

Start date

2008-06-30

Completion date

2009-04-30

Last updated

2009-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Brief summary

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

Detailed 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.

Interventions

DRUGketoprofen in Diractin®

100 mg (b.i.d.)

DRUGPlacebo

100 mg (b.i.d.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

46 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
pain subscale of the WOMAC	week 12

Secondary

Measure	Time frame
Patient global assessment of response to therapy	week 12
function subscale of the WOMAC	week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026