E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Localised painful conditions |
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E.1.1.1 | Medical condition in easily understood language |
Localised painful conditions |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10068757 |
E.1.2 | Term | Musculoskeletal and connective tissue pain and discomfort |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
To assess the clinical efficacy of Z7202 diclofenac DEA medicated plaster (test), versus placebo on pain intensity on motion related to painful conditions (due to ankle sprains and/ or strains), detected by a 100 mm Visual Analogue Scale (VAS), on day 4 |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this study are to assess the clinical efficacy of Z7202 diclofenac DEA medicated plaster in terms of reduction of pain intensity at rest on day 4 and 8; reduction of pain intensity on motion on day 8; rescue medication consumption; global efficacy at the end of treatment; systemic safety and tolerability and local tolerability of Z7202 diclofenac DEA medicated plaster. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients, 18-70 years old
2. Patients with a diagnosis of single localized painful condition due to ankle sprains and/ or strains: the time between injury/onset of pain and treatment has to be less than 24 h, without any pre-treatment (with the exception of local cold treatment)
3. Pain assessment: pain intensity on motion > 50 mm on the 100 mm VAS
4. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
5. Informed Consent: signed written informed consent prior to inclusion in the study. |
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E.4 | Principal exclusion criteria |
1. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study
2. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients including adhesives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study; 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)
3. Diseases: any disease which in the investigator’s judgement may interfere with the study evaluations or affect patient’s safety; patients with neuropathic pain (e.g. neuropathic low back pain, post-herpetic nevralgia, diabetic neuropathy), osteoarthritis, fibromyalgia; tendonitis or tenosynovitis; history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); diagnosis including dementia, anxia, mental retardation; patients
suffering from multiple sclerosis, Parkinson’s Disease, Restless Legs Syndrome;
significant kidney or liver disease; history of gastrointestinal ulcer or bleeding; blood coagulation disorders; rheumatic pain conditions; low back pain; known neoplastic diseases
4. Skin conditions: skin conditions affecting the site of application (i.e. wound, eczema, weeping dermatitis); open lesions
5. Serious injuries, including a fracture, nerve injury and a tear of ligament, muscle or cartilage
6. Medications: use of paracetamol within 24 h before the inclusion; use of aspirin or NSAIDs within 36 h before the inclusion; use of topical preparations applied to the painful region within 7 days before the inclusion, including herbal products; use of opioids within 7 days before the inclusion; systemic and dermatological preparations of corticosteroids 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 from
local cold application within 48 h before the inclusion
7. Clinical trials: participation in the evaluation of any drug within 3 months prior to the start of the study
8. Drug, alcohol: history of drug or alcohol abuse
9. Pregnancy:
- pregnant or lactating women;
- women of childbearing potential if not using a reliable method of contraception;
- women of not child-bearing potential unless permanently sterilised or in postmenopausal status for at least 2 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the diclofenac DEA medicated plaster versus Placebo in terms of change in pain intensity on motion from baseline to day 4, evaluated using a 100 mm VAS. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary end-points are the comparison between treatments in terms of:
- change in pain intensity at rest from baseline to Day 4 and Day 8, a 100 mm VAS
- change in pain intensity on motion from baseline to Day 8, evaluated using a 100 mm VAS;
- proportion of patients achieving at least 50% pain relief on motion by Day 4, (i.e. responders);
- proportion of patients achieving 20, 50 and 70% pain relief on motion, at any point during the study;
- time to 50% pain relief on motion;
- time to first rescue medication, proportion of patients using rescue medication and amount of rescue medication from randomization until day 4 and at the end of treatment;
- proportion of patients withdrawing due to treatment failure and time to withdrawal due to treatment failure;
- global efficacy evaluation by both investigator and patient at the end of the treatment (day 8);
- systemic safety and tolerability assessed by both investigator and patient;
- local tolerability assessed every day by patient (erythema, itching and burning) during the treatment and investigator (erythema) on days 8 and 15;
- incidence of adverse events and vital signs evaluations. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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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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 |