Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963443
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):

August 20, 2009
August 21, 2009
December 5, 2014
September 2009
March 2012   (Final data collection date for primary outcome measure)
Reduction of nasal congestion and relief of pain [ Time Frame: 4 hours ]
Same as current
Complete list of historical versions of study NCT00963443 on Archive Site
  • Area under the curve for nasal airflow conductance from baseline [ Time Frame: 1h, 2h, 3h ]
  • Sum of subjective nasal congestion intensity differences [ Time Frame: 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 ]
  • Global assessment of nasal congestion [ Time Frame: 3 days ]
  • Global assessment of pain relief [ Time Frame: 3 days ]
  • Sum of pain intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ]
  • Total pain relief [ Time Frame: 1, 2, 3 days ]
  • Adverse Event collection and physical examination [ Time Frame: 3 days ]
Same as current
Not Provided
Not Provided
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.
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Common Cold
  • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
    2 Sachets of 500 mg Aspirin Complex.
  • Drug: Pseudoephedrine
    2 Sachets of 30 mg Pseudoephedrine
  • Drug: Placebo
    Matching Placebo
  • Experimental: Arm 1
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
    • Drug: Pseudoephedrine
  • Active Comparator: Arm 2
    Intervention: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Active Comparator: Arm 3
    Intervention: Drug: Pseudoephedrine
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years old
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
2009-011355-46 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Study Director: Bayer Study Director Bayer
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP