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Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00963443
First received: August 20, 2009
Last updated: April 14, 2013
Last verified: April 2013

August 20, 2009
April 14, 2013
September 2009
March 2012   (final data collection date for primary outcome measure)
Reduction of nasal congestion and relief of pain [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963443 on ClinicalTrials.gov Archive Site
  • Area under the curve for nasal airflow conductance from baseline [ Time Frame: 1h, 2h, 3h ] [ Designated as safety issue: No ]
  • Sum of subjective nasal congestion intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total subjective nasal congestion relief [ Time Frame: 1h, 2h, 3h,4 h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Global assessment of nasal congestion [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Global assessment of pain relief [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sum of pain intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total pain relief [ Time Frame: 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Adverse Event collection and physical examination [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Area under the curve for nasal airflow conductance from baseline [ Time Frame: 1h, 2h, 3h ] [ Designated as safety issue: No ]
  • Sum of subjective nasal congestion intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total subjective nasal congestion relief [ Time Frame: 1h, 2h, 3h,4 h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Global assessment of nasal congestion [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Global assessment of pain relief [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sum of pain intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total pain relief [ Time Frame: 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Adverse Event collection and physical examination [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
833
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00963443
13700, 2009-011355-46
No
Therapeutic Area Head, Bayer Comsumer Care Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2013

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