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Completed

NCT Number: NCT00963443

Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiff, South Glamorgan, CF1 3US, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion criteria

  • < 18 years old

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

2 Sachets of 500 mg Aspirin Complex.

pseudoephedrine

Drug

2 Sachets of 30 mg Pseudoephedrine

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Reduction of nasal congestion and relief of pain

    Time frame: 4 hours

Secondary outcomes

  1. Area under the curve for nasal airflow conductance from baseline

    Time frame: 1h, 2h, 3h

  2. Sum of subjective nasal congestion intensity differences

    Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days

  3. Total subjective nasal congestion relief

    Time frame: 1h, 2h, 3h,4 h and 1, 2, 3 days

  4. Global assessment of nasal congestion

    Time frame: 3 days

  5. Global assessment of pain relief

    Time frame: 3 days

  6. Sum of pain intensity differences

    Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days

  7. Total pain relief

    Time frame: 1, 2, 3 days

  8. Adverse Event collection and physical examination

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2009
Registry last updated
Dec 5, 2014

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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