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Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Common Cold

Intervention: Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug); Pseudoephedrine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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 AspirinŽ Complex.

Clinical Details

Official 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction of nasal congestion and relief of pain

Secondary outcome:

Area under the curve for nasal airflow conductance from baseline

Sum of subjective nasal congestion intensity differences

Total subjective nasal congestion relief

Global assessment of nasal congestion

Global assessment of pain relief

Sum of pain intensity differences

Total pain relief

Adverse Event collection and physical examination


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patient in general good health with suspected viral upper respiratory tract infection

(common cold) Exclusion Criteria:

- < 18 years old

Locations and Contacts

Cardiff, South Glamorgan CF1 3US, United Kingdom
Additional Information

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Starting date: September 2009
Last updated: December 4, 2014

Page last updated: August 20, 2015

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