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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

NCT ID: NCT01465009

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Common Cold Pharyngitis Tonsillitis

Keywords

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Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Type DRUG

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

Arm 2

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Acetylsalicylic acid (Aspirin, BAYE4465)

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

Intervention Type DRUG

Paracetamol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Consumer Care, Inc.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Reading, Berkshire, United Kingdom

Site Status

Manchester, Greater Manchester, United Kingdom

Site Status

Chorley, Lancashire, United Kingdom

Site Status

Wigan, Lancashire, United Kingdom

Site Status

Liverpool, Merseyside, United Kingdom

Site Status

Liverpool, Merseyside, United Kingdom

Site Status

Cardiff, South Glamorgan, United Kingdom

Site Status

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11381

Identifier Type: -

Identifier Source: org_study_id