Painful, acute ankle sprains, as a model of general traumatic soft-tissue injuries MedDRA version: 8.1 Level: LLT Classification code 10002549
Conditions
Interventions
Trade Name: Ketospray 10% spray
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: Ketoprofen
CAS Number: 22071-15-4
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concen
Sponsors
CSC Pharmaceuticals Handels GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject diagnosed with an acute ankle sprain of external lateral ligament defined as degree I or II in the O’Donoghue classification or as stage I or II in the Castaing classification (for details see references as well as short reminder at the end of this document), and fulfilling the following criteria: - Post-traumatic sprain caused by medial inversion of the ankle. - Pain on active motion assessed by the patient must correspond to = 50 mm VAS at baseline. - Uncomplicated ankle sprain, i.e. treatable without surgery, and including injuries not associated with concomitant problems that contraindicate early motion and rehabilitation. - Onset within 48 hours prior to the first visit, medically untreated as yet except for paracetamol (last dose not later than 6h prior to the baseline visit) or other type II analgesics e.g. dextropropoxifen (last dose not later than 12h prior to the baseline visit) or ice packs (last application not later than 1 hour prior to the baseline visit). · Male or female outpatients · Aged 18-65 years · If female of childbearing potential: - agree to maintain reliable birth control (oral contraceptive, IUDs, sterilized partner) throughout the study. - or with negative (urine) pregnancy test in countries where required (by the Ethic’s Committee). · Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for follow-up visits. · Subject has provided written informed consent prior to undergoing any study procedure. 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
Exclusion criteria: Criteria concerning ankle sprain: Subject: · Who has a complicated ankle sprain, i.e. - Requiring surgery - Not meeting degree I or II or stage I or II for ankle sprain according to O’Donoghue and Castaing classification, respectively. - Where radiography is indicated according to the Ottawa rules. · Who has undergone another course of treatment for the ankle sprain e.g. cast or other immobilizing (i.e. inhibition of dorso-flexion) bandage or system. · Who has recurrent ankle sprain (i.e. a previous episode within the last 6 months). · Who has bilateral ankle sprain. · Who has had a major surgery of the affected joint during the 6 months preceding inclusion. Criteria concerning previous and concomitant medication and other therapy: Subject: · Who has started treatment with antidepressants, muscle relaxants or tranquilizers within 1 month of enrolment, or who is likely to change the dose of such concomitant drugs during the course of the study. · Who is taking or has taken any form, including topical, of opioid, NSAID (except for low dose aspirin 200mg or less that was started at least 30 days prior to enrolment, and that will not be changed during the study), or any other analgesic within 7 days of inclusion (or 15 days for oxicams). · Who is unable to walk without aid or using crutches. · Who has taken any other investigational drug within the past 30 days. · Receiving therapy with agents known or likely to interact with study drug, see section 8 of protocol. Criteria concerning the subject: Subject: · Who is pregnant or breast-feeding. · Who has a known hypersensitivity to ketoprofen, or who has an allergy manifested by attacks of asthma, urticaria, or acute rhinitis following treatment with aspirin or other agents with cyclo- oxygenase inhibiting activity such as non-steroidal anti-inflammatory drugs (NSAIDs). · Who has a known hypersensitivity to paracetamol. · Who is suffering from known liver, kidney, cardiovascular, pulmonary or hematological disease. · Who is suffering from phlebitis. · Who has suffered from an ulcer, gastrointestinal bleeding and/or perforation within 2 years prior to the trial. · With evidence or history of drug or alcohol abuse. · Who has previously participated in this clinical study. · Who has skin lesions or wounds in the affected area on the ankle to be treated. · With mental impairment limiting the ability to comply with study requirements. · Who, in the opinion of the investigator, is unable or unwilling to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary study objectives: To evaluate the efficacy of Ketoprofen 10% Cutaneous Spray compared to placebo in patients with acute ankle sprains. ;Secondary Objective: Secondary study objectives: To evaluate the safety of Ketoprofen 10% Cutaneous Spray in patients with acute ankle sprains.;Primary end point(s): Change in Pain on Active Motion VAS (mm) between Baseline and Day 3. | — |
Countries
Hungary
Outcome results
None listed