Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA) | Completed
Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
Health Conditions
  • Osteoarthritis of the Knee
Completed
Recruitment Status
NCT00716547
Primary Trial ID Number
Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Primary Outcome Measures
  • pain subscale of the WOMAC; week 12
Secondary Outcome Measures
  • Patient global assessment of response to therapy; week 12; function subscale of the WOMAC; week 12
Research Question
  • The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Czech Republic; Germany; Poland; United Kingdom
Participant Sex
Both
Participant Age Range
46 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; ketoprofen in Diractin®; 50 mg (b.i.d.); [1]; Drug; ketoprofen in Diractin®; 100 mg (b.i.d.); [2]; Drug; Placebo; b.i.d.; [4]; Drug; celecoxib; 100 mg (b.i.d.); [3]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
Secondary Trial Identifying Number
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Website
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Study Funded By
IDEA AG
Funder Type
Sorry, this information is not available
Study Sponsored By
IDEA AG
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 Jul 2008

Last Updated

15 Oct 2009

Date Record Refreshed on UKCTG

31 Jul 2015