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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963443
Other study ID # 13700
Secondary ID 2009-011355-46
Status Completed
Phase Phase 3
First received August 20, 2009
Last updated December 4, 2014
Start date September 2009
Est. completion date March 2012

Study information

Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 833
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- < 18 years old

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
Placebo
Matching Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of nasal congestion and relief of pain 4 hours No
Secondary Area under the curve for nasal airflow conductance from baseline 1h, 2h, 3h No
Secondary Sum of subjective nasal congestion intensity differences 1h, 2h, 3h, 4h and 1, 2, 3 days No
Secondary Total subjective nasal congestion relief 1h, 2h, 3h,4 h and 1, 2, 3 days No
Secondary Global assessment of nasal congestion 3 days No
Secondary Global assessment of pain relief 3 days No
Secondary Sum of pain intensity differences 1h, 2h, 3h, 4h and 1, 2, 3 days No
Secondary Total pain relief 1, 2, 3 days No
Secondary Adverse Event collection and physical examination 3 days Yes
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