Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00963443

Collaborator

(none)

833

Enrollment

Location

Arms

Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Drug: Pseudoephedrine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

833 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) 2 Sachets of 500 mg Aspirin Complex. Drug: Pseudoephedrine 2 Sachets of 30 mg Pseudoephedrine
Active Comparator: Arm 2	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) 2 Sachets of 500 mg Aspirin Complex.
Active Comparator: Arm 3	Drug: Pseudoephedrine 2 Sachets of 30 mg Pseudoephedrine
Placebo Comparator: Arm 4	Drug: Placebo Matching Placebo

Outcome Measures

Primary Outcome Measures

Reduction of nasal congestion and relief of pain [4 hours]

Secondary Outcome Measures

Area under the curve for nasal airflow conductance from baseline [1h, 2h, 3h]
Sum of subjective nasal congestion intensity differences [1h, 2h, 3h, 4h and 1, 2, 3 days]
Total subjective nasal congestion relief [1h, 2h, 3h,4 h and 1, 2, 3 days]
Global assessment of nasal congestion [3 days]
Global assessment of pain relief [3 days]
Sum of pain intensity differences [1h, 2h, 3h, 4h and 1, 2, 3 days]
Total pain relief [1, 2, 3 days]
Adverse Event collection and physical examination [3 days]