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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,016

Participants

Timeline

Start Date

December 23, 2005

Primary Completion Date

May 14, 2007

Study Completion Date

May 14, 2007

Conditions
Common ColdPharyngitis
Interventions
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.

Trial Locations (59)

11021

New York

11743

New York

16010

Genova

Masone

Serra Riccò

16011

Arenzano

16017

Isola del Cantone

16019

Ronco Scrivia

16100

Pegli

16125

Genova

16128

Genova

16129

Genova

16131

Genova

16137

Genova

16143

Genova

16149

Genova

16150

Rivarolo

16151

Sampierdarena

16161

Genova

16162

Genova

17019

Varazze

17021

Alassio

17025

Loano

17031

Albenga

17047

Quiliano

58022

Follonica

58048

Civitella Marittima

58054

Scansano

58100

Grosseto

Grossetto

Orbetello

81107

Bratislava

84101

Bratislava

84104

Bratislava

84107

Bratislava

85101

Bratislava

85102

Bratislava

85105

Bratislava

90031

Stupava

90201

Pezinok

87-408

Ciechocin

96-116

Dębowa Góra

40-226

Katowice

40-520

Katowice

40-752

Katowice

31-215

Krakow

93-105

Lodz

05-500

Piaseczno

96-100

Skierniewice

71-140

Szczecin

71-502

Szczecin

87-100

Torun

01-493

Warsaw

01-961

Warsaw

02-091

Warsaw

02-097

Warsaw

02-793

Warsaw

03-185

Warsaw

41-800

Zabrze

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY