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

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:

MedlinePlus related topics: Common Cold Sore Throat Tonsils and Adenoids

Drug Information available for: Aspirin Acetaminophen

U.S. FDA Resources

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

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:

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 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

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
Respiratory Tract Infections
Pharyngitis
Tonsillitis
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Acetaminophen
Aspirin
Antipyretics

Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013