Symptomatic Treatment of Common Cold Symptoms

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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

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)

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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