Primary symptomatic osteoarthritis of the hip and/or knee
Conditions
Interventions
Trade Name: Olfen®-100 Depocaps®
Product Name: Olfen®-100 Depocaps®
Product Code: 46851
Pharmaceutical Form: Capsule*
INN or Proposed INN: Diclofenac
Other descriptive name: Olfen-100 Depocaps
Concent
Sponsors
Mepha Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent obtained. •Male and female Caucasian outpatients between 18 and 75 years. •Symptoms of primary osteoarthritis since at least 3 months. •Osteoarthritic knee and/or hip pain for most days of the prior month and a pain intensity at rest on a horizontal 100 mm VAS pain scale of = 50 mm at baseline in treatment/NSAID naïve OA patients or pre-treated OA patients after completion of the wash-out period. •Radiologically diagnosed OA (Kellgren and Lawrence Index grade II or III). •American Rheumatism Association (ARA) functional class I, II or III. •Analgesic treatment required for at least the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Hospital in-patients or patients permanently at bed rest. •Pregnant and/or lactating women. •Childbearing potential in female patients without adequate contraceptive measures •OA patients with a current exacerbation of symptoms (flares) requiring additional or relevant change in concomitant treatment during the study. •Intra-articular corticosteroid or hyaluronic acid injections into the target joint or into other joint(s) during the previous three months. •Other systemic (oral or parenteral) corticosteroid administration during the previous four weeks. •Systemic (oral or parenteral) anticoagulants during the previous four weeks. •Use of NSAIDs or any analgesic treatment within 3 – 7 days – depending on the half life of previous NSAID medication prior to first study dose except paracetamol or low dose aspirin •Physiotherapy during the wash-out and/or treatment phase. •Clinical signs of or laboratory evidence for severe hepatic, renal, pulmonary, cardiac, metabolic, psychiatric, cancer (other than squamous cell of the skin) or haematologic diseases, number of leucocytes < 3.500/µl, neutropenia < 1.500/µl, thrombocytes < 100.000/µl; known positive HIV, lues, hepatitis B and/or C. •History of or manifest gastrointestinal ulcer or gastrointestinal bleeding; haemorrhagic diathesis. •Any contraindication to NSAIDs, at the discretion of the investigator. •History of skin reactions or hypersensitivity or allergy to NSAIDs including aspirin, diclofenac or paracetamol. •Known intolerance or hypersensitivity to any of the ingredients of the investigational medicinal products. •History of drug-induced porphyria. •Significant injury of the target joint - hip or knee - within last 6 months. •Secondary arthritis: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget´s disease, haemophilic arthropathy, psoriasis arthritis, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson´s disease, primary osteochondromatosis, heritable disorders (e. g. hypermobility), collagen gene mutations •Concomitant rheumatic diseases (e.g. fibromyalgia, lupus erythematodes, mixed connective tissue disease). •Metabolic disorders: crystal deposition diseases (Chondrocalcinosis), alkaptonuria. •Osteonecrosis or aseptic necrosis. •Colitis ulcerosa or Morbus Crohn. •Use of assistive devices other than a cane (walking stick) or knee brace. •Alcoholism, drug dependency (defined as impaired / questionable reliability) as well as neurotic personality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to demonstrate the clinical non-inferiority of the analgesic effect of OlfenTM-100 SR Depocaps® compared to Voltaren® Retard 100 by assessing changes in VAS pain score at visit 3 (day 14) compared to baseline, despite a lower Cmax for OlfenTM-100 SR Depocaps®.;Secondary Objective: ;Primary end point(s): For clinical trials in OA with symptom modifying drugs pain attributable to the target joint is recommended as primary endpoint (CPMP/EWP/784/97). In this trial the 100 mm Visual Analogue Scale (VAS) will be used to assess OA pain in the hip or knee. It can be defined that patients with VAS pain scores of 30 mm or less are categorised as having mild pain, those with scores of 70 mm or more as having severe pain and those from 31 mm to 69 mm, moderate pain (Kelly, 2001). Since functional disability is also an important additional endpoint for symptom modifying drugs (CPMP/EWP/784/97) the ARA classification of Rheumatoid Arthritis (Arnett et al, 1997) will be used as inclusion criteria. Other secondary endpoints include: global rating of effectiveness by patients and investigators and consumption of paracetamol as escape medications for pain relief (CPMP/EWP/784/97). | — |
Countries
Germany
Outcome results
None listed