Trial Condition(s):
Common Cold
Acetylsalicylic acid combined with pseudoephedrine in common cold
Bayer Identifier:
13700
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Exclusion Criteria
- < 18 years old
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Cardiff University Cardiff, United Kingdom, CF1 3US | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Reduction of nasal congestion and relief of painTimeframe: 4 hours
Secondary Outcome
- Area under the curve for nasal airflow conductance from baselineTimeframe: 1h, 2h, 3h
- Sum of subjective nasal congestion intensity differencesTimeframe: 1h, 2h, 3h, 4h and 1, 2, 3 days
- Total subjective nasal congestion reliefTimeframe: 1h, 2h, 3h,4 h and 1, 2, 3 days
- Global assessment of nasal congestionTimeframe: 3 days
- Global assessment of pain reliefTimeframe: 3 days
- Sum of pain intensity differencesTimeframe: 1h, 2h, 3h, 4h and 1, 2, 3 days
- Total pain reliefTimeframe: 1, 2, 3 days
- Adverse Event collection and physical examinationTimeframe: 3 days
Additional Information
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