Trial Condition(s):

Common Cold

Symptomatic treatment of common cold symptoms

Bayer Identifier:

11756

ClinicalTrials.gov Identifier:

NCT01033526

EudraCT Number:

Not Available

Study Completed

Trial Purpose

A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.

Inclusion Criteria
- Age between 18 and 65 years - Onset of cold symptoms within 48 hours before screening - Objective symptoms of common cold - Subjective symptoms of common cold
Exclusion Criteria
- Pregnancy or lactation period - Active peptic ulcer - Hemorrhagic diathesis - History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding - Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens

Trial Summary

Enrollment Goal
388
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

ASL Prov Varese - Lombardia

Varese, Italy, 21100

Status
Completed
 
Locations

Ambulatorio Dr Mauro Pigni

Fagnano Olona, Italy, 21054

Status
Completed
 
Locations

Ambulatorio Dr. Maurizio Viganò

Vergiate, Italy, 21029

Status
Completed
 
Locations

Ambulatorio Dr. Claudio Bulla

Capriate San Gervasio, Italy, 24042

Status
Completed
 
Locations

Ambulatorio Dr. Luigi Donzelli

Verdello, Italy, 24049

Status
Completed
 
Locations

Ambulatorio Dr. Alessandro Filippi

Mozzanica, Italy, 24050

Status
Completed
 
Locations

Ambulatorio Dr Raimondo Giuliana

Brembate, Italy, 24041

Status
Completed
 
Locations

Ambulatorio Dr Sergio Nicoli

Borgo di Terzo, Italy, 24060

Status
Completed
 
Locations

Ambulatorio Dr. Marina Pezzano

Covo, Italy, 24050

Status
Completed
 
Locations

Ambulatorio Dr. Paola Pini

Seriate, Italy, 24068

Status
Completed
 
Locations

Ambulatorio Dr Francesco Rizza

Cologno al Serio, Italy, 24055

Status
Completed
 
Locations

Ambulatorio Dr Manuela Mariuz

Dalmine, Italy, 24044

Status
Completed
 
Locations

Investigative Site

Fagnano Olona, Italy, 21054

Status
Completed
 
Locations

Investigative Site

Calusco d'Adda, Italy, 24033

Status
Completed
 
Locations

Investigative Site

Cavaria, Italy, 21044

Status
Completed
 
Locations

Investigative Site

Cunardo, Italy, 21035

Status
Completed
 
Locations

Ambulatorio Dr. Mauro Calzolari

Vedano Olona, Italy, 21040

Status
Completed
 
Locations

Ambulatorio Dr. Valter Colombo

Solbiate Olona, Italy, 21058

Status
Completed
 
Locations

Ambulatorio Dr Marco Passamonti

Fagnano Olona, Italy, 21054

Status
Completed
 
Locations

Ambulatorio Dr. Vincenzo Spada

Induno Olona, Italy, 21056

Status
Completed
 
Locations

Ambulatorio Dr. Ettore Mantione

Cologno al Serio, Italy, 24055

Status
Completed
 
Locations

Ambulatorio Dr. Claudio Mascaretti

Caravaggio, Italy, 24043

Status
Completed
 
Locations

Ambulatorio Dr. Fabio Villa

Villa d'Adda, Italy, 24030

Status
Completed
 
Locations

Ambulatorio Dr. Mario Zappa

Casazza, Italy, 24060

Status
Completed
 
Locations

Investigative Site

Angera, Italy, 21021

Status
Completed
 
Locations

Investigative Site

Sesto Calende, Italy, 21018

Status
Completed
 
Locations

Investigative Site

Comerio, Italy, 21025

Status
Completed
 
Locations

Investigative Site

Carnago, Italy, 21040

Status
Completed
 
Locations

Investigative Site

Ponte San Pietro, Italy, 24036

Status
Completed
 
Locations

Investigative Site

Vertova, Italy, 24029

Status
Completed
 
Locations

Investigative Site

Albano Sant'Alessandro, Italy, 24061

Status
Completed
 

Trial Design