NCT01062360

Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine

A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,016 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.

Conditions

• Common Cold
• Pharyngitis

Interventions

Type	Name	Description
DRUG	Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine	Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
DRUG	Acetylsalicylic Acid (Aspirin, BAYE4465)	Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
DRUG	Pseudoephedrine	Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
DRUG	Placebo	Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Timeline

• Start date: 2005-12-23
• Primary completion: 2007-05-14
• Completion: 2007-05-14
• First posted: 2010-02-04
• Last updated: 2017-09-01

Locations

59 sites across 4 countries: United States, Italy, Poland, Slovakia