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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465009
• Other study ID #: 11381
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2011
• Last updated: December 10, 2014
• Start date: November 2003
• Est. completion date: March 2005

Study information

• Verified date: November 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Pharyngitis
• Tonsillitis

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAYE4465)
Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol
• Paracetamol
Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
• Placebo
Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol		For 6 hours after drug intake	No
Secondary	Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo		For 6 hours after drug intake	No
Secondary	Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol		For 6 hours after drug intake	No
Secondary	Total pain relief of Acetylsalicylic Acid in comparison to Placebo		For 6 hours after drug intake	No
Secondary	Evaluation of Upper Respiratory Tract Infection symtoms		2 hours after drug intake	No
Secondary	Adverse Event collection		Up to 17 days after Screening	Yes

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