Acute pain in soft-tissue injuries of lower limbs, except toes
Conditions
Interventions
Pharmaceutical Form: Cutaneous stick
Other descriptive name: Ketoprofeno
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Fastum gel
Pharmaceutical
Sponsors
MDS Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 70 years 2. Diagnosis of painful soft tissue injury of lower limbs ( sprains, strains and contusions)except toes of recent onset (less than 48 hours) 3. Spontaneous pain at rest = 35 mm on the Huskisson's 100-mm VAS 4. Females of child-bearing potential must be: - surgically incapable of pregnancy, or - practising an acceptable method of birth control (i.e. oral hormonal contraceptives or Intrauterine Device) 5. Understanding of the study and agreement to give a written informed consent, 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with an open lesion or serious injury, including a fracture, nerve injury and a tear of ligament, muscle or cartilage - Painful soft tissue injury associated with osteoarthritis or rheumatoid arthritis, - Painful soft tissue injury requiring orthopaedic or surgical treatment (except elastic bandage), - Contraindications to ketoprofen or any NSAID - Known hypersensitivity to ketoprofen or to any other component of the patch or gel formulation, or any NSAID - Contraindication to paracetamol or to any of the ingredients of the supplied rescue medication, - Known hypersensitivity to paracetamol or any other component of the supplied rescue medication - Use of: .paracetamol within 12 hours before the inclusion .aspirin or NSAIDs within 12 hours before the inclusion . topical medications applied to the painful region since the injury .opioids within 7 days before the inclusion .corticosteroid drugs by any route of administration within 30 days before the inclusion .any physical therapy (physiotherapy and kinesis-therapy) within 24 hours before the inclusion (except cold application) .any investigational drugs in the last 30 days prior to inclusion. - Skin conditions affecting the site of application (wound, eczema, weeping dermatitis…). - Patients suspected to have a high potential for non-compliance to the study procedures and/or of non-completion of the study for non-medical reasons, according to the Investigator’s judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the overall clinical efficacy and safety of ketoprofen TDS patch versus Ketoprofen gel in the treatment of acute pain related to soft-tissue injuries of lower limbs except toes (ankle and knee sprains, strains and contusions);Secondary Objective: 1. To compare the two treatments in terms of - pain at daily activities intensity improvement - overall change in clinical condition - onset of analgesic effect after the first application of topical treatment - change in quality of sleep, pain intensity, pain relief, symptoms at injury (swelling, stiffness and bruise) site and use of rescue medication (paracetamol consumption) - of global evaluation of the therapy (assessed by the investigator), and in terms of overall judgement of the efficacy and tolerability (assessed by the patient) - of tolerability, based on the assessment and the recording of the adverse events (AEs) up to 7 days after the last patch application, and physical examination - judgment on treatment acceptability and convenience (assessed by the patient) and 2. to investigate possible connections between response to treatment and baseline characteristics of patients included. ;Primary end point(s): To assess spontaneous pain at rest during the last 24 hours, at visit 2 from baseline | — |
Countries
Spain
Outcome results
None listed