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Completed

NCT Number: NCT01033526

Symptomatic Treatment of Common Cold Symptoms

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Borgo di Terzo, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in Common Cold Profile (sum of WURSS domains 1 182 3)

    Time frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)

  2. Changes in Global Cold Severity (WURSS domain 1)

    Time frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)

  3. Changes in Cold Symptoms (WURSS domain 2)

    Time frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)

  4. Changes in Cold-specific Functional Impairments (WURSS domain 3)

    Time frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)

  5. Changes in Global Cold Severity (WURSS domain 4)

    Time frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)

  6. Adverse Event Collection

    Time frame: Until end of study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 16, 2009
Registry last updated
Dec 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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