Diagnosis of single localized post-traumatic painful condition MedDRA version: 14.0 Level: PT Classification code 10065016 Term: Post-traumatic pain System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Diclofenac diethylammonium salt (DEA) medicated plaster
Product Code: Z7202
Pharmaceutical Form: Medicated plaster
CAS Number: 78213-16-8
Current Sponsor code: Z7202
Concentration unit:
Sponsors
Zambon S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 314 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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.;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparation between treatments in term of change of spontaneous pain intensity at daily activities from baseline to day 8, evaluated using a 4-point scale; change in spontaneous pain intensity at rest from baseline to day 8, evaluated using a 100 mm VAS; time to 50% pain relief; proportion of patients achiving 50% pain relief; time to first rescue medication and total amount of rescue medication; proportion of withdrawn patients and time to withdrawal due to treatment failure; global efficacy evaliation by both investigator and patient at day 5, at day 8 and at day 15; local tolerability assessed by patient (erythema, itching and burning) every day during a treatment period and by investigator (erythema) on days 8 and 15; incidence of adverse events, vital signes and laboratory evaluation.;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Czech Republic, Hungary
Contacts
Public ContactAdonella Aletti
Zambon S.p.A.
Outcome results
None listed