E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Muscular Pain |
akutna mišična bolečina |
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E.1.1.1 | Medical condition in easily understood language |
acute muscular pain |
akutna mišična bolečina |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
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 |
The proportion of subjects with clinically significant decrease in pain intensity (ΔNRS = 2 points) after 7 days in a test group in comparison to the group receiving placebo. |
Delež oseb, ki se jim bolečina klinično pomembno zniža (ΔNRS = 2 točki) po 7 dneh v testni skupini v primerjavi s skupino, ki prejema placebo. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female • 30-65 years • Acute muscular pain • Pain strength 4-6 according to NRS
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• odrasli, moški in ženske • 30 – 65 let • Akutna mišična bolečina • Jakost bolečine 4-6 po 11 stopenjski numerični lestvici (NRS) |
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E.4 | Principal exclusion criteria |
• Chronic pain • Chronic use of analgetics • Suspicion of injury • Known allergies
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• kronična bolečina • kronična uporaba analgetikov • sum na hujše poškodbe • poznane alergije
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects with clinically significant decrease in pain intensity (ΔNRS = 2 points) after 7 days in the test group compared to the group receiving placebo. |
Delež oseb, ki se jim bolečina klinično pomembno zniža (ΔNRS = 2 točki) po 7 dneh v testni skupini v primerjavi s skupino, ki prejema placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 7 days of treatment |
Po 7 dneh zdravljenja |
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E.5.2 | Secondary end point(s) |
• The proportion of subjects with clinically significant decrease in pain intensity (ΔNRS = 2 points) after 4 days in a test group in comparison to the group receiving placebo. • Decrease in pain intensity (NRS) after 7 days from baseline in a test group in comparison to the group receiving placebo. • Decrease in pain intensity (NRS) after 4 days from baseline in a test group in comparison to the group receiving placebo. • The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 7 days in a test group in comparison to the group receiving placebo. • The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 4 days in a test group in comparison to the group receiving placebo. • The amount of intake of rescue medication in a test group in comparison to the group receiving placebo, for 7 days of the study duration. • The incidence of adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration. • The incidence of serious adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration • Quality of Life improvement (SF-36v2 with PIQ-6, acute recall)
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• Delež oseb, ki se jim bolečina klinično pomembno zniža (ΔNRS = 2 točki) po 4 dneh v testni skupini v primerjavi s skupino, ki prejema placebo. • Zmanjšanje stopnje bolečine (NRS) po 7 dneh od izhodiščne vrednosti v testni skupini v primerjavi s skupino, ki prejema placebo. • Zmanjšanje stopnje bolečine (NRS) po 4 dneh od izhodiščne vrednosti v testni skupini v primerjavi s skupino, ki prejema placebo. • Delež oseb, ki se jim je bolečina znižala za 33% točk NRS po 7 dneh v testni skupini v primerjavi s skupino, ki prejema placebo. • Delež oseb, ki se jim je bolečina znižala za 33% točk NRS po 4 dneh v testni skupini v primerjavi s skupino, ki prejema placebo. • Količina zaužitega reševalnega zdravila pri testni skupni v primerjavi s skupino, ki prejema placebo, tekom 7 dni trajanja raziskave. • Pojavnost neželenih dogodkov v testni skupini v primerjavi s skupino, ki prejema placebo, tekom 7 dni trajanja raziskave. • Pojavnost resnih neželenih dogodkov v testni skupini v primerjavi s skupino, ki prejema placebo, tekom 7 dni trajanja raziskave. • Izboljšanje kvalitete življenja (SF-36).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The proportion of subjects with clinically significant decrease in pain intensity (ΔNRS = 2 points), Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, - will be evaluated after 4 days of treatment
Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, amount of intake of rescue medication, incidence of adverse events, incidence of serious adverse events, Quality of Life improvement - will be evaluated after 7 days of treatment |
Delež oseb, ki se jim je bolečina klinično pomembno zniža (ΔNRS = 2 točki), Zmanjšanje stopnje bolečine (NRS), Delež oseb, ki se jim je bolečina znižala za 33% točk NRS - bo ocenjeno po 4 dneh zdravljenja
Zmanjšanje stopnje bolečine (NRS), Delež oseb, ki se jim je bolečina znižala za 33% točk NRS, Količina zaužitega reševalnega zdravila, Pojavnost neželenih dogodkov, Pojavnost resnih neželenih dogodkov, Izboljšanje kvalitete življenja - bo ocenjeno po 7 dneh zdravljenja |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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LVLS - Last Visit of the Last Subject |
LVLS - Zadnji obisk zadnjega preizkušanca |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 7 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 7 |