Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
Phase 3
Completed
- Conditions
- Common Cold
- Interventions
- Registration Number
- NCT00963443
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 833
Inclusion Criteria
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Exclusion Criteria
- < 18 years old
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4 Placebo - Arm 2 Acetylsalicylic Acid (Aspirin, BAYE4465) - Arm 1 Acetylsalicylic Acid (Aspirin, BAYE4465) - Arm 1 Pseudoephedrine - Arm 3 Pseudoephedrine -
- Primary Outcome Measures
Name Time Method Reduction of nasal congestion and relief of pain 4 hours
- Secondary Outcome Measures
Name Time Method Total pain relief 1, 2, 3 days 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 Sum of pain intensity differences 1h, 2h, 3h, 4h and 1, 2, 3 days Adverse Event collection and physical examination 3 days