Patients with acute traumatic blunt soft tissue injury/contusion of the limbs. MedDRA version: 14.1 Level: LLT Classification code 10041292 Term: Soft tissue injury NOS System Organ Class: 100000004863
Conditions
Interventions
Product Name: Diclofenac 1% gel
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac Diethylamine
CAS Number: 78213-16-8
Other descriptive name: DICLOFENAC DIETHYLAMINE
Concentration unit: mg/g m
Sponsors
EPIFARMA SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients of either gender and aged 18-65 years; • Patients with acute traumatic blunt soft tissue injury/contusion of the limbs (joints, muscles, tendons and ligaments); • If female and of child-bearing potential, the patient must be non-nursing and should not become pregnant throughout the whole study duration; all females of child-bearing potential must have a negative serum or urine pregnancy test prior the first administration; • Satisfactory general health status as determined by the investigator based on medical history and physical examination; • Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial, and be willing to complete the required assessments. 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 176 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Patients unwilling to give an informed consent approval; • Patients with known osteo-musculo-articular lesions; • Pregnancy or lactation period; • Women with childbearing potential who are not using adequate methods to avoid pregnancy; • Presence of concurrent skin disorders or open wounds in the area to be treated; • History of alcohol or drug abuse; • History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; • Known hypersensitivity to non-steroid anti-inflammatory drugs, and in particular to acetylsalicylic acid; • Any patient, in the investigators opinion not considered suitable for enrolment (anticipated poor compliance by the patient) or who, for whatever reason, are unlikely to comply with study requirements; • Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of paracetamol) in the week before the study. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study; • Any other treatment or medication that can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis); in the week before the study. • Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that interferes with the conduct of the trial; • History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening; • History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results; • Any cognitive impairment that would, in the opinion of the investigator, preclude study participation or compliance with the study procedures (e.g. Alzheimer´s dementia); • Participation in any other clinical study within 30 days prior to the screening; • Employees of the centre (i.e. principal investigator, co-investigator, study coordinator, other staff member, and employees) with direct involvement in the study or other studies conducted or directed by the investigator in the centre, as well as relatives of employees or of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the efficacy of Diclofenac 1% gel in improving pain symptom in patients with acute traumatic blunt soft tissue injury/contusion of the limbs over a treatment period of 15 days. Efficacy will be determined by means of a Visual Analogue Scale (VAS) for Pain. The VAS is a validated instrument for assessing degree of pain. It consists of a horizontal line, 100 mm in length, where patients put a vertical mark on the line indicating their current perception of pain.;Secondary Objective: • Time to resolution of pain; • Pain assessment by 100 mm VAS, at rest by patient at each site visit; • Consumption of rescue medication (paracetamol); • Global assessment of efficacy by investigator ; • Tolerability and safety of Diclofenac 1% gel will be assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, laboratory evaluations, ECGs, and vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature). Safety analyses will be done for the safety population. ;Primary end point(s): • VAS for pain at rest 96 ± 4 hours after treatment start in comparison with equivalent placebo gel. ;Timepoint(s) of evaluation of this end point: at Visit 3 (96 hours± 4after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to resolution of pain; • Pain assessment by VAS, at rest by patient at each site visit; • Consumption of rescue medication (paracetamol); • Global assessment of efficacy by investigator; • Tolerability and safety of Diclofenac 1% gel, will be assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, laboratory evaluations, ECGs, and vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature). Safety analyses will be done for the safety population. ;Timepoint(s) of evaluation of this end point: Pain assessment at each Visit 1, 2, 3,4, 5 and 6 but related to the time of pain resolution | — |
Countries
Lithuania, Poland, Russian Federation
Contacts
Public ContactRegulatory Affairs Office
EPIFARMA SRL
Outcome results
None listed