Localised painful conditions MedDRA version: 14.1 Level: HLT Classification code 10068757 Term: Musculoskeletal and connective tissue pain and discomfort System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Diclofenac Diethylamine
Product Code: Z7202
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Diclofenac diethyl ammonium
CAS Number: 78213-16-8
Current Sponsor code: Z7202
Oth
Sponsors
Zambon S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 cooperate 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Days 4, 8 or 15 | — |
Countries
Estonia, Lithuania
Contacts
Public ContactIsabella Salerio
Zambon S.p.A
Outcome results
None listed