check_circleStudy Completed

Common Cold, Pharyngitis, Tonsillitis

Bayer Identifier:

11381

ClinicalTrials.gov Identifier:

NCT01465009

EudraCT Number:

Not Available

EU CT Number:

Not Available
Placebo and active controlled study to compare the efficacy of Aspirin and Paracetamol in treatment of sore throat associated with a common cold

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and female patients
    - Onset of common cold within the past 5 days
    - Current sore throat
    - Confirmed presence of a tonsillo-pharyngitis
  • - 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

Trial summary

Enrollment Goal
508
Trial Dates
November 2003 - March 2005
Phase
Phase IV
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cardiff, CF1 3US, United Kingdom
Completed
Birmingham, B15 2SQ, United Kingdom
Completed
Chorley, PR7 1NY, United Kingdom
Completed
Liverpool, L22 0LG, United Kingdom
Completed
Liverpool, L1 9AD, United Kingdom
Completed
Manchester, M15 6SX, United Kingdom
Completed
Reading, RG2 7AG, United Kingdom
Completed
Wigan, WN6 9EW, United Kingdom

Primary Outcome

  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
    date_rangeTime Frame:
    For 6 hours after drug intake
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo
    date_rangeTime Frame:
    For 6 hours after drug intake
    enhanced_encryption
    Safety Issue:
    no
  • Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol
    date_rangeTime Frame:
    For 6 hours after drug intake
    enhanced_encryption
    Safety Issue:
    no
  • Total pain relief of Acetylsalicylic Acid in comparison to Placebo
    date_rangeTime Frame:
    For 6 hours after drug intake
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of Upper Respiratory Tract Infection symtoms
    date_rangeTime Frame:
    2 hours after drug intake
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event collection
    date_rangeTime Frame:
    Up to 17 days after Screening
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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