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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465009

Enrollment

508

Registered

2011-11-04

Start date

2003-11-30

Completion date

2005-03-31

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold, Pharyngitis, Tonsillitis

Keywords

Sore Throat

Brief 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.

Interventions

DRUGAcetylsalicylic acid (Aspirin, BAYE4465)

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

DRUGParacetamol

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol	For 6 hours after drug intake

Secondary

Measure	Time frame
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo	For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol	For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Placebo	For 6 hours after drug intake
Evaluation of Upper Respiratory Tract Infection symtoms	2 hours after drug intake
Adverse Event collection	Up to 17 days after Screening

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026