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Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00963443
First Posted: August 21, 2009
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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.

Condition Intervention Phase
Common Cold Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Drug: Pseudoephedrine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Reduction of nasal congestion and relief of pain [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • Area under the curve for nasal airflow conductance from baseline [ Time Frame: 1h, 2h, 3h ]
  • Sum of subjective nasal congestion intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ]
  • Total subjective nasal congestion relief [ Time Frame: 1h, 2h, 3h,4 h and 1, 2, 3 days ]
  • Global assessment of nasal congestion [ Time Frame: 3 days ]
  • Global assessment of pain relief [ Time Frame: 3 days ]
  • Sum of pain intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ]
  • Total pain relief [ Time Frame: 1, 2, 3 days ]
  • Adverse Event collection and physical examination [ Time Frame: 3 days ]

Enrollment: 833
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
Drug: Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
Active Comparator: Arm 2 Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
Active Comparator: Arm 3 Drug: Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
Placebo Comparator: Arm 4 Drug: Placebo
Matching Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion Criteria:

  • < 18 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963443


Locations
United Kingdom
Cardiff, South Glamorgan, United Kingdom, CF1 3US
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00963443     History of Changes
Other Study ID Numbers: 13700
2009-011355-46 ( EudraCT Number )
First Submitted: August 20, 2009
First Posted: August 21, 2009
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Aspirin Complex
Acetylsalicylic Acid
Pseudoephedrine
Common Cold

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Aspirin
Pseudoephedrine
Ephedrine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents