patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains) MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ketoprofen
Product Code: SKP-021
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: KETOPROFEN
CAS Number: 22071-15-4
Current Sponsor code: SKP-021
Concentration unit: mg millig
Sponsors
PROMO INTERNATIONAL SRL
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Time needed to reach the status of responders -Overall changes in VAS score -Improvement of clinical symptoms related to the disease -Changes in the MPAC scale with particular attention to mood profile -Overall physician and patient rating on the treatment result;Timepoint(s) of evaluation of this end point: Time needed to reach the status of responder -the Kaplan-Meier curve and the curves of the two groups will be compared by the Log-rank test; Overall changes in VAS score. Improvement of clinical symptoms: difference in the improvement proportions of two groups will be analyzed by the logistic regression. Changes in the MPAC scale: the three VAS scales will be evaluated for the overall changes in VAS score; for the 8 descriptors of pain and the overall ratings -Cochran-Mantel-Haenszel test. Vital Signs: the changes from baseline will be compared between groups by the ANCOVA. AEs: the incidence will be compared between groups by the chi square test or Fisher’s exact test | — |
Countries
Italy
Contacts
Public ContactRICERCA CLINICA
GB PHARMA SERVICES
Outcome results
None listed