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

December 10, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 7AG
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M15 6SX
    • Lancashire
      • Chorley, Lancashire, United Kingdom, PR7 1NY
      • Wigan, Lancashire, United Kingdom, WN6 9EW
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L22 0LG
      • Liverpool, Merseyside, United Kingdom, L1 9AD
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF1 3US
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2SQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Paracetamol
Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
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
Placebo Comparator: Arm 3
Drug: Placebo
Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
Time Frame: For 6 hours after drug intake
For 6 hours after drug intake

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo
Time Frame: For 6 hours after drug intake
For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol
Time Frame: For 6 hours after drug intake
For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Placebo
Time Frame: For 6 hours after drug intake
For 6 hours after drug intake
Evaluation of Upper Respiratory Tract Infection symtoms
Time Frame: 2 hours after drug intake
2 hours after drug intake
Adverse Event collection
Time Frame: Up to 17 days after Screening
Up to 17 days after Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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