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Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00963443
First received: August 20, 2009
Last updated: April 14, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Reduction of nasal congestion and relief of pain [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve for nasal airflow conductance from baseline [ Time Frame: 1h, 2h, 3h ] [ Designated as safety issue: No ]
  • Sum of subjective nasal congestion intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total subjective nasal congestion relief [ Time Frame: 1h, 2h, 3h,4 h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Global assessment of nasal congestion [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Global assessment of pain relief [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sum of pain intensity differences [ Time Frame: 1h, 2h, 3h, 4h and 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Total pain relief [ Time Frame: 1, 2, 3 days ] [ Designated as safety issue: No ]
  • Adverse Event collection and physical examination [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Comsumer Care Inc.
ClinicalTrials.gov Identifier: NCT00963443     History of Changes
Other Study ID Numbers: 13700, 2009-011355-46
Study First Received: August 20, 2009
Last Updated: April 14, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Aspirin
Pseudoephedrine
Ephedrine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013