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Completed

NCT Number: NCT01465009

Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of 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.

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Key information

Conditions

Common Cold Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Reading, Berkshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

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

Paracetamol

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: For 6 hours after drug intake

Secondary outcomes

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

    Time frame: For 6 hours after drug intake

  2. Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol

    Time frame: For 6 hours after drug intake

  3. Total pain relief of Acetylsalicylic Acid in comparison to Placebo

    Time frame: For 6 hours after drug intake

  4. Evaluation of Upper Respiratory Tract Infection symtoms

    Time frame: 2 hours after drug intake

  5. Adverse Event collection

    Time frame: Up to 17 days after Screening

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Nov 4, 2011
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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