check_circleStudy Completed
Common Cold
Bayer Identifier:
13700
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 YearsTrial summary
Enrollment Goal
833Trial Dates
September 2009 - March 2012Phase
Phase 3Could I Receive a placebo
YesProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Cardiff University | Cardiff, CF1 3US, United Kingdom |
Primary Outcome
- Reduction of nasal congestion and relief of paindate_rangeTime Frame:4 hoursenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Area under the curve for nasal airflow conductance from baselinedate_rangeTime Frame:1h, 2h, 3henhanced_encryptionnoSafety Issue:
- Sum of subjective nasal congestion intensity differencesdate_rangeTime Frame:1h, 2h, 3h, 4h and 1, 2, 3 daysenhanced_encryptionnoSafety Issue:
- Total subjective nasal congestion reliefdate_rangeTime Frame:1h, 2h, 3h,4 h and 1, 2, 3 daysenhanced_encryptionnoSafety Issue:
- Global assessment of nasal congestiondate_rangeTime Frame:3 daysenhanced_encryptionnoSafety Issue:
- Global assessment of pain reliefdate_rangeTime Frame:3 daysenhanced_encryptionnoSafety Issue:
- Sum of pain intensity differencesdate_rangeTime Frame:1h, 2h, 3h, 4h and 1, 2, 3 daysenhanced_encryptionnoSafety Issue:
- Total pain reliefdate_rangeTime Frame:1, 2, 3 daysenhanced_encryptionnoSafety Issue:
- Adverse Event collection and physical examinationdate_rangeTime Frame:3 daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
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