Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Common Cold
Intervention: Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug); Pseudoephedrine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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 AspirinŽ
Complex.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Reduction of nasal congestion and relief of pain
Secondary outcome: Area under the curve for nasal airflow conductance from baselineSum 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient in general good health with suspected viral upper respiratory tract infection
(common cold)
Exclusion Criteria:
- < 18 years old
Locations and Contacts
Cardiff, South Glamorgan CF1 3US, United Kingdom
Additional Information
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Starting date: September 2009
Last updated: December 4, 2014
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