Symptomatic Treatment of Common Cold Symptoms

Bayer388 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

388

Conditions

Common Cold

Interventions

Aspirin (Acetylsalicylic acid, BAYE4465)DRUG

1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days

PlaceboDRUG

1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Borgo di Terzo, Bergamo, Italy

Unnamed facility

Brembate, Bergamo, Italy

Outcomes

Primary Outcomes

Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline

Time frame: 2 hours following intake of the first study medication dose