Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

Bayer

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Drug: Placebo; Drug: Pseudoephedrine; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963443

2009-011355-46 (EudraCT Number)

13700

Details and patient eligibility

About

The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.

Enrollment: 833 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion criteria

• < 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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833 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Pseudoephedrine

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 2

Active Comparator group

Treatment:

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

Active Comparator group

Treatment:

Drug: Pseudoephedrine

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo