Treatment of osteoarthritis of the knee MedDRA version: 9.1 Level: LLT Classification code 10031161 Term: Osteoarthritis
Conditions
Interventions
Product Name: Diractin®
Pharmaceutical Form: Gel
INN or Proposed INN: Ketoprofen
CAS Number: 22071-15-4
Current Sponsor code: 033/23
Concentration unit: mg/g milligram(s)/gram
Concentration type: equa
Sponsors
IDEA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met to include a patient in the study: • Informed consent signed and dated • Age older than 45 years (if age of 18-45, radiological confirmation of diagnosis of knee OA is required) • Subject has a primary diagnosis of Functional Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee, defined by the following: Knee pain and at least 4 of the following 6: o Age >50 o Morning stiffness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Difference in WOMAC pain rating for question 1 or the total average pain score between B1 and B2 > 2 • Skin lesions or dermatological diseases in the treatment area • Extreme obesity (BMI > 37) • Directly or indirectly involved in the conduct and administration of this study (i.e. principal investigator, sub-investigator, study co-ordinators, other study staff, employees of IDEA AG, IDEA contractors and/or their families) • 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 • Morbus Meulengracht/Gilbert syndrome • 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, omeprazole, paracetamol and to ingredients of the IMP including galactose • Preexisting asthma bronchiale or bronchospasm after taking aspirin or other NSAIDs • Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout of the index knee, pseudogout, systemic lupus erythematodes, or mixed connective tissue disease • Symptomatic ipsilateral hip OA or predominant retropatellar knee OA • Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin • Ischemic heart disease requiring drug therapy • Peripheral arterial disease and/or cerebrovascular disease and/or vascular surgery. • 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 = 5 times the ULN • Within 3 months prior or during the study o Intraarticular injections of hyaluronic acid products in the index knee o Arthroscopy of the index knee o Tricyclics • Within 2 months prior or during the study o Oral, inhaled or parenteral corticosteroids (depot steroids 6 months) o Change in oral treatment regimen of glucosamine, chondroitin sulfate, shark cartilage, methylensulfonylmethan (MSM), Vitamin E, diacerin or nutraceuticals • Within 1 month prior or during the study o Intraarticular injections of corticosteroids in the index knee within 1 months prior to screening or during the study o Antiepileptic drugs o Acupuncture or physical therapy of the index knee including ice/heat packs and massage • Unable to discontinue therapy with proton-pump inhibitors, H2 inhibitors and analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or any other drug approved or used for the treatment of pain for the dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is: • Change from baseline at Week 12 on the entire pain subscale of the WOMAC (NRS) ;Main Objective: To evaluate the efficacy of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to osteoarthritis (OA) of the knee.;Secondary Objective: To evaluate the overall safety of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to OA of the knee. | — |
Countries
Czech Republic, Germany
Outcome results
None listed