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.

Bayer0 sites833 target enrollmentSeptember 2009

ConditionsCommon Cold

InterventionsPlacebo Acetylsalicylic Acid (Aspirin, BAYE4465)Pseudoephedrine

DrugsAcetylsalicylic Acid (Aspirin, BAYE4465)Pseudoephedrine Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Common Cold
Sponsor: Bayer
Enrollment: 833
Primary Endpoint: Reduction of nasal congestion and relief of pain
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•\< 18 years old

Arms & Interventions

Arm 4

Intervention: Placebo

Arm 1

Intervention: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 1

Intervention: Pseudoephedrine

Arm 2

Intervention: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

Intervention: Pseudoephedrine

Outcomes

Primary Outcomes

Reduction of nasal congestion and relief of pain

Time Frame: 4 hours

Secondary Outcomes

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