Evaluation of therapeutic equivalence of diclofenac gel 1% formulation compared to Voltaren emulGel 1% gel in subjects with traumatic pathology: a double blind, randomized, phase III multicentre study. - ND

• Conditions: Painful and traumatic inflammation of the joints, muscles, tendons and ligaments.; MedDRA version: 9.1Level: HLGTClassification code 10028393; MedDRA version: 9.1Level: HLGTClassification code 10023213; MedDRA version: 9.1Level: HLGTClassification code 10043237; MedDRA version: 9.1Level: HLGTClassification code 10028302

• Registration Number: EUCTR2010-020521-40-IT
• Lead Sponsor: EPIFARMA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects willing and able to understand and sign an approved informed consent form; 2. Provision of written informed consent; 3. Subjects of either gender and aged 18-65 years: 4. Subjects with traumatic disease of the joints, muscles, tendons and ligaments; 5. If female and of child-bearing potential, the patient must be non-nursing and practicing an effective method of contraception throughout the study duration. All females of child-bearing potential must have a negative serum or urine pregnancy test prior the first administration.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects unwilling to give an approved informed consent form; 2. Subjects with known osteo-musculo-articular lesions; 3. Female of child-bearing potential and lactating; 4. Presence of dermatological diseases in the area of application; 5. Treatment with any NSAID or drug containing diclofenac; 6. History of alcohol or drug abuse; 7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; 8. Subjects who, for whatever reason are unlikely to comply with study requirements; 9. Subjects who have received any investigational drug and/or non-approved drug within 12 weeks before the study entry; 10. Subjects who were previously enrolled in this study; 11. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the subjective response to the treatment with the formulation of diclofenac gel 1% in reducing pain as self-measured by using a 10 points graduate VAS scale.;Secondary Objective: Secondary objectives of the study are: • To evaluate the the effectiveness of the formulation of diclofenac gel 1% in reducing pain as measured at centre by using a VAS scale. • To evaluate the tolerability and safety of formulation of diclofenac gel 1% recording the incidence of local and overall adverse events, and vital signs (heart rate and blood pressure). Blood samples will be collected to monitor blood levels of diclofenac for safety purpose.;Primary end point(s): The primary efficacy variable of this study is the response to treatment.