Symptomatic Treatment of Common Cold Symptoms

Bayer

Status and phase: Completed; Phase 4

Conditions: Common Cold

Treatments: Drug: Aspirin (Acetylsalicylic acid, BAYE4465); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033526

11756

EudraCT: 2004-004683-71

Details and patient eligibility

About

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.

Enrollment: 388 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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388 participants in 2 patient groups, including a placebo group

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Experimental group

Treatment:

Drug: Aspirin (Acetylsalicylic acid, BAYE4465)