Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

December 4, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

833

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF1 3US

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
Experimental: Arm 1
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
Drug: Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
Placebo Comparator: Arm 4
Drug: Placebo
Matching Placebo
Active Comparator: Arm 3
Drug: Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of nasal congestion and relief of pain
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve for nasal airflow conductance from baseline
Time Frame: 1h, 2h, 3h
1h, 2h, 3h
Sum of subjective nasal congestion intensity differences
Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
1h, 2h, 3h, 4h and 1, 2, 3 days
Total subjective nasal congestion relief
Time Frame: 1h, 2h, 3h,4 h and 1, 2, 3 days
1h, 2h, 3h,4 h and 1, 2, 3 days
Global assessment of nasal congestion
Time Frame: 3 days
3 days
Global assessment of pain relief
Time Frame: 3 days
3 days
Sum of pain intensity differences
Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
1h, 2h, 3h, 4h and 1, 2, 3 days
Total pain relief
Time Frame: 1, 2, 3 days
1, 2, 3 days
Adverse Event collection and physical examination
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13700
  • 2009-011355-46 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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