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

Primary Purpose

Common Cold, Pharyngitis, Tonsillitis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Acetylsalicylic acid (Aspirin, BAYE4465)

Paracetamol

Placebo

About this trial

This is an interventional treatment trial for Common Cold focused on measuring Sore Throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol

Secondary Outcome Measures

Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo

Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol

Total pain relief of Acetylsalicylic Acid in comparison to Placebo

Evaluation of Upper Respiratory Tract Infection symtoms

Adverse Event collection

Full Information

NCT ID

NCT01465009

First Posted

May 17, 2011

Last Updated

December 10, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01465009

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Cold, Pharyngitis, Tonsillitis

Keywords

Sore Throat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

508 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Description

Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

Primary Outcome Measure Information:

Title

Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol

Time Frame

For 6 hours after drug intake

Secondary Outcome Measure Information:

Title

Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo

Time Frame

For 6 hours after drug intake

Title

Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol

Time Frame

For 6 hours after drug intake

Title

Total pain relief of Acetylsalicylic Acid in comparison to Placebo

Time Frame

For 6 hours after drug intake

Title

Evaluation of Upper Respiratory Tract Infection symtoms

Time Frame

2 hours after drug intake

Title

Adverse Event collection

Time Frame

Up to 17 days after Screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Reading

State/Province

Berkshire

ZIP/Postal Code

RG2 7AG

Country

United Kingdom

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M15 6SX

Country

United Kingdom

City

Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 1NY

Country

United Kingdom

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 9EW

Country

United Kingdom

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L1 9AD

Country

United Kingdom

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L22 0LG

Country

United Kingdom

City

Cardiff

State/Province

South Glamorgan

ZIP/Postal Code

CF1 3US

Country

United Kingdom

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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