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.

Gedeon Richter Plc.0 sites300 target enrollmentStarted: November 19, 2009Last updated: March 19, 2012

Overview

No summary available.

•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

•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).

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