E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028819 |
E.1.2 | Term | Nausea vomiting and diarrhea |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019211 |
E.1.2 | Term | Headache |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017822 |
E.1.2 | Term | Gastric ulcer |
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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 demonstrate that: 1. Ibalgin Extra Fast® is superior over placebo in overall analgesic efficacy. This conclusion will be drawn if and only if the lower limit of the two-sided 95% confidence interval for the treatment difference (test-placebo) in TOTPAR is greater than zero. 2. Ibalgin Extra Fast® is non-inferior to Nurofen forte® (the active comparator) in overall analgesic efficacy. This conclusion will be drawn if and only if 1. is concluded and two-sided 95% confidence interval for the treatment difference (test-active comparator) in TOTPAR lies entirely to the right of the non-inferiority margin. 3. Ibalgin Extra Fast® is superior over Nurofen forte® (the active comparator) in the onset of action. This conclusion will be drawn if and only if 2. is concluded and the lower limit of the two-sided 95% confidence interval for the treatment difference (test-active comparator) in PAR45 is greater than zero.
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E.2.2 | Secondary objectives of the trial |
To assess Superiority of Nurofen forte® (the active comparator) over placebo in TOTPAR (to demonstrate assay sensitivity), Global Assessment of Medication , Remedication time, Time to pain half gone, Time to any pain relief, Time to meaningful pain relief, Sum of Pain Intensity Difference (SPID), Safety
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent obtained
• Subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone • Subjects between 18 – 60 years, both sexes
• Negative pregnancy test in females with childbearing potential • Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages up to 6 hrs post dose • Ability to read, comprehend, and record information required by protocol.
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E.4 | Principal exclusion criteria |
• Acute purulent infammation in the area of the planned bony-impacted 3rd molar removal • Another acute or chronic painful physical condition • Use of any analgesics, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages from midnigt of the night prior to surgery • Subject has a history or presence of significant organ disease • Active gastric or duodenal ulcer • Clotting and a haematogenesis disorders • Any other disease or condition which may interfere with study assessments as judged by the investigator • Subjects taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months • Subjects with history of hypersensitivity to the study drug or its excipients • Subjects likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator • Pregnancy or breast-feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate that: 1. Ibalgin Extra Fast® is superior over placebo in overall analgesic efficacy. This conclusion will be drawn if and only if the lower limit of the two-sided 95% confidence interval for the treatment difference (test-placebo) in TOTPAR is greater than zero. 2. Ibalgin Extra Fast® is non-inferior to Nurofen forte® (the active comparator) in overall analgesic efficacy. This conclusion will be drawn if and only if 1. is concluded and two-sided 95% confidence interval for the treatment difference (test-active comparator) in TOTPAR lies entirely to the right of the non-inferiority margin. 3. Ibalgin Extra Fast® is superior over Nurofen forte® (the active comparator) in the onset of action. This conclusion will be drawn if and only if 2. is concluded and the lower limit of the two-sided 95% confidence interval for the treatment difference (test-active comparator) in PAR45 is greater than zero.
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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 | Yes |
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 | 5 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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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 | |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |