Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01465009
First received: May 17, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.


Condition Intervention Phase
Common Cold
Pharyngitis
Tonsillitis
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Drug: Paracetamol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol [ Time Frame: For 6 hours after drug intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo [ Time Frame: For 6 hours after drug intake ] [ Designated as safety issue: No ]
  • Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol [ Time Frame: For 6 hours after drug intake ] [ Designated as safety issue: No ]
  • Total pain relief of Acetylsalicylic Acid in comparison to Placebo [ Time Frame: For 6 hours after drug intake ] [ Designated as safety issue: No ]
  • Evaluation of Upper Respiratory Tract Infection symtoms [ Time Frame: 2 hours after drug intake ] [ Designated as safety issue: No ]
  • Adverse Event collection [ Time Frame: Up to 17 days after Screening ] [ Designated as safety issue: Yes ]

Enrollment: 508
Study Start Date: November 2003
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol
Active Comparator: Arm 2 Drug: Paracetamol
Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
Placebo Comparator: Arm 3 Drug: Placebo
Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • Onset of common cold within the past 5 days
  • Current sore throat
  • Confirmed presence of a tonsillo-pharyngitis

Exclusion Criteria:

  • Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
  • Pregnant or lactating women
  • History or acute state of peptic ulceration or gastrointestinal bleeding
  • History of bleeding tendency
  • History of asthma
  • Inability to breathe through the nose or a history of chronic mouth breathing
  • Other exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465009

Locations
United Kingdom
Reading, Berkshire, United Kingdom, RG2 7AG
Manchester, Greater Manchester, United Kingdom, M15 6SX
Chorley, Lancashire, United Kingdom, PR7 1NY
Wigan, Lancashire, United Kingdom, WN6 9EW
Liverpool, Merseyside, United Kingdom, L22 0LG
Liverpool, Merseyside, United Kingdom, L1 9AD
Cardiff, South Glamorgan, United Kingdom, CF1 3US
Birmingham, West Midlands, United Kingdom, B15 2SQ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care, Inc.
ClinicalTrials.gov Identifier: NCT01465009     History of Changes
Other Study ID Numbers: 11381
Study First Received: May 17, 2011
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Sore Throat

Additional relevant MeSH terms:
Common Cold
Pharyngitis
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Virus Diseases
Acetaminophen
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014