E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary symptomatic osteoarthritis of the hip and/or knee |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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®. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Diclofenac Voltaren® Retard 100 |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the clinical part of the study is concluded after the planned number of patients has completed all phases of the study, when the last visit of the last trial subject/patient has taken place. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |