E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of single localized post-traumatic painful condition |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065016 |
E.1.2 | Term | Post-traumatic pain |
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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 study is to assess the clinical efficacy of Diclofenac DEA medicated plaster versus Flector® medicated plaster on spontaneous pain intensity at rest related to post-traumatic painful conditions (due to sprains/strains/contusions) detected by a 100 mm VAS, on day 5. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this study are the following: - to assess the clinical efficacy of Diclofenac DEA plaster in terms of: reduction of spontaneous pain at daily activities on day 8; reduction of spontaneous pain at rest on day 8; rescue medication consumption; - to assess global efficacy of the therapy at the end of the treatment; - to assess systemic safety and tolerability of the therapy; - to assess local tolerability of the study treatments.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patients, 18-70 years old inclusive with a diagnosis of single localized post-traumatic painful condition (the time between injury and treatment has to be less than 24 h, without any pre-treatment, with the exception of local cold treatment); spontaneous pain at rest > 50 mm on the 100 mm VAS. |
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E.4 | Principal exclusion criteria |
Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients including adhesives; history of anaphylaxis to drugs or allergic reactions in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) to aspirin or other non steroidal anti-inflammatory drugs (NSAIDs) and to acetaminophen (paracetamol); patients with neuropathic pain (e.g. neuropathic low back pain, diabetic neuropathy, post-herpetic nevralgia), osteoarthritis pain, fibromyalgia; history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); diagnosis including dementia, anxia, mental retardation; multiple sclerosis, Parkinson’s Disease, Restless Legs Syndrome; significant kidney or liver disease; history of gastrointestinal ulcer or bleeding; blood coagulation disorders; skin conditions affecting the site of application (e.g. wound, eczema, weeping dermatitis); open lesion or serious injury, including a fracture nerve injury and a tear of ligament, muscle or cartilage; use of paracetamol within 24 h before the inclusion; use of aspirin or NSAIDs within 36 h before the inclusion; use of topical medications applied to the painful region within 7 days before the inclusion; use of opioids within 7 days before the inclusion; use of corticosteroid drugs by any route of administration within 30 days before the inclusion; use of myorelaxant drugs within 24 h before the inclusion; use of any physical therapy (physiotherapy and kinesis-therapy) apart local cold application within 48 h before the inclusion; pregnant or lactating women, or women of childbearing age not using a reliable method of contraception, or women of not child-bearing potential if not permanently sterilised or if not in post-menopausal status from at least two years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the DEA medicated plaster (test) versus Flector® medicated plaster (reference) in term of change in spontaneous pain intensity at rest from baseline to day 5, evaluated using a 100 mm VAS. |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 26 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | No |
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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Date of Last Patient Last Visit |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |