E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cold related pain/fever e.g. sore throat, headache, ear eache, sinus pressure and nasal congestion. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028735 |
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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 |
verificare la superiorita' della combinazione fissa di ASA 500 mg e PE 30 mg in confronto al solo ASA 500 mg(granuli, 2 bustine) nella congestione nasale nonche la superiorita' della stessa combinazione alla stessa dose in confronto alla sola PE 30 mg (granuli, 2 bustine) nel dolore di gola.
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E.2.2 | Secondary objectives of the trial |
1)Safety e tollerabilita' 2) differenze nell'intensita' di dolore verso il basale a vari tempi fino a tre giorni dopo la prima dose 3)Scomparsa del dolore totale verso il basale a vari tempi fino a tre giorni dopo la prima dose
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Male and female patients between 18-65 years of age • Onset of cold symptoms within the previous 96 hours (4 days) • Current complaint of at least moderate sore throat baseline, confirmed by a score ≥ 6 on the sore throat pain scale (numerical 0 - 10 scale) • Current complaint of at least moderate nasal congestion at baseline, confirmed by a score ≥ 6 on the nasal congestion scale (numerical 0 – 10 scale) • History of other symptoms associated with upper respiratory tract infection (URTI) in the past 4 days • Other findings of upper respiratory tract infection, confirmed on the physical examination • Agree to comply with the study requirements • Written informed consent prior to enrollment in the study
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E.4 | Principal exclusion criteria |
Patients must not have one or more of the following conditions: • Pregnant or lactating females • Uncontrolled chronic diseases • History of hypersensitivity (allergic reaction) to ASA, any other NSAID or PE • Any disease which significantly compromises breathing or interferes with the patients assessment of sore throat • History of -, or active peptic ulcer • Severe impaired hepatic function • Severe impaired renal function • Severe not compensated heart insufficiency • Severe hypertension • Severe coronary heart disease • Simultaneous intake of monoamino-oxidase inhibitors • Use of menthol-containing tissues within the previous 2 hours • Taking of any menthol-containing product within previous 4 hours • Use of any local or systemic short-acting cough and cold preparations in the past 6 hours • Use of any local or systemic long-acting cough and cold preparations in the past 12 hours • Any analgesic within previous 12 hours • Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection • Currently taking or had taken anticoagulants, corticoids, NSAIDs, methotrexate or lithium • Taken part in another clinical trial within the last 30 days • Already participated in this study • Any significant disease or condition which, in the investigators opinion, may interfere with the study objectives
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E.5 End points |
E.5.1 | Primary end point(s) |
1) congestione nasale: area sotto la curva calcolata sui punteggi corretti per i valori basali di congestione nasale(NCS) nelle due ore iniziali dopo la somministrazione (AUC-NCS 2ore) 2) dolore di gola: SPID 2 ore, inteso come la somma delle differenze di intensita' del dolore nelle 2 ore iniziali dell'osservazione
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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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |