check_circleStudy Completed

Common Cold

Bayer Identifier:

13700

ClinicalTrials.gov Identifier:

NCT00963443

EudraCT Number:

2009-011355-46

EU CT Number:

Not Available
Acetylsalicylic acid combined with pseudoephedrine in common cold

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patient in general good health with suspected viral upper respiratory tract infection (common cold)
  • - < 18 years old

Trial summary

Enrollment Goal
833
Trial Dates
September 2009 - March 2012
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cardiff UniversityCardiff, CF1 3US, United Kingdom

Primary Outcome

  • Reduction of nasal congestion and relief of pain
    date_rangeTime Frame:
    4 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Area under the curve for nasal airflow conductance from baseline
    date_rangeTime Frame:
    1h, 2h, 3h
    enhanced_encryption
    Safety Issue:
    no
  • Sum of subjective nasal congestion intensity differences
    date_rangeTime Frame:
    1h, 2h, 3h, 4h and 1, 2, 3 days
    enhanced_encryption
    Safety Issue:
    no
  • Total subjective nasal congestion relief
    date_rangeTime Frame:
    1h, 2h, 3h,4 h and 1, 2, 3 days
    enhanced_encryption
    Safety Issue:
    no
  • Global assessment of nasal congestion
    date_rangeTime Frame:
    3 days
    enhanced_encryption
    Safety Issue:
    no
  • Global assessment of pain relief
    date_rangeTime Frame:
    3 days
    enhanced_encryption
    Safety Issue:
    no
  • Sum of pain intensity differences
    date_rangeTime Frame:
    1h, 2h, 3h, 4h and 1, 2, 3 days
    enhanced_encryption
    Safety Issue:
    no
  • Total pain relief
    date_rangeTime Frame:
    1, 2, 3 days
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event collection and physical examination
    date_rangeTime Frame:
    3 days
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here and search for EMA Websynopsis results