Cold related pain/fever e.g. sore throat, headache, ear eache, sinus pressure and nasal congestion. MedDRA version: 6.1 Level: PT Classification code 10028735
Conditions
Interventions
Trade Name: Aspirin Complex
Pharmaceutical Form: Granules
INN or Proposed INN: acetylsalicyclic acid
Concentration unit: mg milligram(s)
Sponsors
BAYER
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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 ; Main Objective: 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. ; 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 | — |
Countries
Italy
Outcome results
None listed