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

Phase 4

Completed

• Conditions: Pharyngitis; Tonsillitis; Common Cold
• Interventions: Drug: Placebo; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Paracetamol

• Registration Number: NCT01465009
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-03
• Study First Submitted: 2011-05-17
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Placebo	-
Arm 1	Acetylsalicylic acid (Aspirin, BAYE4465)	-
Arm 2	Paracetamol	-

Primary Outcome Measures

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

Secondary Outcome Measures

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