Clinical trial to evaluate if SKP-021, a 0.3% ketoprofen patch has an efficacy at least equal to diclofenac sodium patch in patients with back pain, bruise, contusion, sprain, strains

• Conditions: patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains); MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005661-20-IT
• Lead Sponsor: PROMO INTERNATIONAL SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

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

Inclusion Criteria

Out-patients of both sexes, aged between 18-65 years, able to give informed consent and to complete the diary will be included if have traumatic disease (e.g.: bruise, contusion, sprain, etc.), with presenting frank symptoms of inflammation, such as pain (VAS >50mm), myalgia and swelling, within 2 days of suffering trauma; if the patient has more than one affected site, one alone is to be treated, whichever severe.
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 680
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients will be excluded mainly if: too wide the affected site, needing other anti-inflammatory analgesic than the study drug for the underlying disease, obese, with history of drug allergy or with aspirin asthma, with a skin wound or skin disease at the test site, pregnancy or lactating women.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: compare the efficacy of SKP-021 (medicated patch containing ketoprofen as an active ingredient) on pain in patients with traumatic disease versus Voltadol? as standard treatment;Secondary Objective: evaluate the effect of treatments not only on pain, but also on mood and on daily activities and to evaluate the safety of the two treatments;Primary end point(s): Number of responders patients at the end of treatment period, i.e.: patients with reduced VAS score of at least 50% versus baseline condition.;Timepoint(s) of evaluation of this end point: At the end of the treatment period the proportions of responders (50% reduction at least of VAS score versus baseline condition) of the two groups will be compared by the chi square test. <br>The difference between treatment effects and its one-sided 97.5% confidence interval will be calculated and non-inferiority will be declared if the lower limit of the confidence interval will lie above -d.