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.
2 other identifiers
interventional
833
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedDecember 5, 2014
December 1, 2014
2.5 years
August 20, 2009
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of nasal congestion and relief of pain
4 hours
Secondary Outcomes (8)
Area under the curve for nasal airflow conductance from baseline
1h, 2h, 3h
Sum of subjective nasal congestion intensity differences
1h, 2h, 3h, 4h and 1, 2, 3 days
Total subjective nasal congestion relief
1h, 2h, 3h,4 h and 1, 2, 3 days
Global assessment of nasal congestion
3 days
Global assessment of pain relief
3 days
- +3 more secondary outcomes
Study Arms (4)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORArm 4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
You may not qualify if:
- \< 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Cardiff, South Glamorgan, CF1 3US, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 21, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
December 5, 2014
Record last verified: 2014-12