A randomized, multicenter, double-blind, parallel study to compare the efficacy and safety profile of RGH-507 (tolperisone-containing) gel versus a ketoprofen-containing gel in the treatment of patients with soft tissue injuries.
- Conditions
- acute soft tissue injury minor traumatism (such as: sprain, strain, dislocation,...etc.) or contusionMedDRA version: 12.0Level: PTClassification code 10041291Term: Soft tissue injury
- Registration Number
- EUCTR2009-013864-37-HU
- Lead Sponsor
- Gedeon Richter Plc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•Acute (within 48 hours) soft tissue injury (traumatism or contusion) which accompanies signs of inflammation and pain in one of the extremities, with or without functional loss, with intact skin and requiring local treatment only.
•The maximum spontaneous pain intensity score is =30 mm on the 100 mm pain intensity VAS during the period of 24 hours prior to the randomization, and/or the average spontaneous pain intensity score is =30 mm on the 100 mm pain intensity VAS during the period of 24 hours prior to the randomization.
•Age between 18 and 75 years (inclusive both males and females).
•18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg)
•Signed Inform Consent.
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) yes
F.1.3.1 Number of subjects for this age range
•If the injury requires permanent occlusive dressing or surgical intervention or physiotherapy.
•Uncontrolled hypertension (systolic > 180 mmHg, diastolic > 110 mmHg).
•If QTc > 500 msec.
•Known hypersensitivity to tolperisone or ketoprofen or other NSAIDs or fenofibrate or any of the other ingredients of the study medications,
•Asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
•Any medication to relieve the pain (either systemic or local) must have been discontinued for a period of at least 5 half-life of the drug prior to the enrolment and are not allowed during the whole study period (the list of drugs with their half-life see detailed in section 10.6 Concomitant therapy).
•Any syndrome or alteration which can significantly interfere with the local pain or generate unresolved considerations in its differential.
•Active arthritis in the affected limb.
•Infected skin or fractures, underlying dermatitis or dermatosis associated with the injury.
•Neurologic alterations of different origin which significantly affect the sensory or motoric functions (e.g. diabetic neuropathy).
•History of drug or alcohol abuse within the past 2 years or current chronic or intermittent users of illicit drugs.
•Lactating or pregnant women or women of child-bearing potential* without appropriate contraceptive treatment. Appropriate contraceptive methods are: abstinence or practicing a reliable method of contraception, such as: hormonal contraception (oral contraceptives consisting of an estrogen-progestin combination or progestin alone, transdermally delivered contraceptives, depot injections, intrauterine device), diaphragm+spermicid, condom+spermicid, vasectomised partner.
•Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level.
•Evidence of an uncooperative attitude.
•Patients who have participated in a study of an investigational drug or device within 3 months of this study.
*women without child-bearing potential: if her menstruation have been missing at least 1 year before the screening or she is infertile because of a gynaecological surgical intervention (tubal ligation or hysterectomy).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of RGH-507 (tolperisone-containing) gel versus a ketoprofen-containing gel in the treatment of patients with acute, mild soft tissue injuries.;Secondary Objective: To compare the safety profile of the two different gel preparations.;Primary end point(s): The primary efficacy analysis of the change of mean score on the pain VAS during the last day of the treatment period from that during the baseline day will be the comparison between treatments in the PP population using the two-sample t-test approach. The null hypothesis to be tested is that there is no difference between the primary endpoint after RGH-507 gel and the ketoprofen-containing gel. A secondary analysis will be performed on the ITT population with last observation carried forward when data are complete. All statistical tests will be two-tailed and will be performed at the 0.05 significance level.
- Secondary Outcome Measures
Name Time Method