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Health Condition(s) or Problem
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Osteoarthritis of the Knee
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Lay Summary
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The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg
and 100 mg ketoprofen in Diractin®.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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
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Primary aim
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pain subscale of the WOMAC
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Secondary Aim
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Patient global assessment of response to therapy; week 12; No; function subscale of the WOMAC; week 12; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Leeds
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