E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute soft tissue injury minor traumatism (such as: sprain, strain, dislocation,...etc.) or contusion |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041291 |
E.1.2 | Term | Soft tissue injury |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To compare the safety profile of the two different gel preparations. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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.
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E.4 | Principal exclusion criteria |
• 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).
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |