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

Bayer

Status and phase: Completed; Phase 4

Conditions: Tonsillitis; Pharyngitis; Common Cold

Treatments: Drug: Paracetamol; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465009

11381

Details and patient eligibility

About

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.

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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508 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 2

Active Comparator group

Treatment:

Drug: Paracetamol

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo