NCT01465009

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Cold
• Pharyngitis
• Tonsillitis

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid (Aspirin, BAYE4465)	Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol
DRUG	Paracetamol	Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
DRUG	Placebo	Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

Timeline

• Start date: 2003-11-01
• Completion: 2005-03-01
• First posted: 2011-11-04
• Last updated: 2014-12-11

Locations

8 sites across 1 country: United Kingdom