NCT00963443

Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 833 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Acetylsalicylic Acid (Aspirin, BAYE4465)	2 Sachets of 500 mg Aspirin Complex.
DRUG	Pseudoephedrine	2 Sachets of 30 mg Pseudoephedrine
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-08-21
• Last updated: 2014-12-05

Locations

1 site across 1 country: United Kingdom