Back to resultsAcetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Acetylsalicylic Acid (Aspirin, BAYE4465)
Pseudoephedrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold
Eligibility Criteria
Inclusion Criteria:
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Exclusion Criteria:
- < 18 years old
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Reduction of nasal congestion and relief of pain
Secondary Outcome Measures
Area under the curve for nasal airflow conductance from baseline
Sum of subjective nasal congestion intensity differences
Total subjective nasal congestion relief
Global assessment of nasal congestion
Global assessment of pain relief
Sum of pain intensity differences
Total pain relief
Adverse Event collection and physical examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00963443
Brief Title
Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
833 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention Description
2 Sachets of 500 mg Aspirin Complex.
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine
Intervention Description
2 Sachets of 30 mg Pseudoephedrine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Reduction of nasal congestion and relief of pain
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Area under the curve for nasal airflow conductance from baseline
Time Frame
1h, 2h, 3h
Title
Sum of subjective nasal congestion intensity differences
Time Frame
1h, 2h, 3h, 4h and 1, 2, 3 days
Title
Total subjective nasal congestion relief
Time Frame
1h, 2h, 3h,4 h and 1, 2, 3 days
Title
Global assessment of nasal congestion
Time Frame
3 days
Title
Global assessment of pain relief
Time Frame
3 days
Title
Sum of pain intensity differences
Time Frame
1h, 2h, 3h, 4h and 1, 2, 3 days
Title
Total pain relief
Time Frame
1, 2, 3 days
Title
Adverse Event collection and physical examination
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Exclusion Criteria:
< 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF1 3US
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for EMA Websynopsis results
Learn more about this trial
Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
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