Trial Condition(s):

Common Cold, Pharyngitis

Placebo and active controlled Study to assess efficacy and tolerability of Aspirin plus Pseudoephedrine

Bayer Identifier:

11764

ClinicalTrials.gov Identifier:

NCT01062360

EudraCT Number:

2005-001720-36

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study
Exclusion Criteria
- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.

Trial Summary

Enrollment Goal
1016
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Alassio, Italy, 17021

Status
Completed
 
Locations

Investigative Site

Civitella Paganico, Italy, 58048

Status
Completed
 
Locations

Investigative Site

Follonica, Italy, 58022

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16010

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16128

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16129

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16131

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16137

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16143

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16162

Status
Completed
 
Locations

Investigative Site

Grosseto, Italy, 58100

Status
Completed
 
Locations

Investigative Site

Grossetto, Italy, 58100

Status
Completed
 
Locations

Investigative Site

Isola del Cantone, Italy, 16017

Status
Completed
 
Locations

Investigative Site

Loano, Italy, 17025

Status
Completed
 
Locations

Investigative Site

Masone, Italy, 16010

Status
Completed
 
Locations

Investigative Site

Ronco Scrivia, Italy, 16019

Status
Completed
 
Locations

Investigative Site

Sampierdarena, Italy, 16151

Status
Completed
 
Locations

Investigative Site

Scansano, Italy, 58054

Status
Completed
 
Locations

Investigative Site

Serra Ricco, Italy, 16010

Status
Completed
 
Locations

Investigative Site

Ciechocin, Poland, 87-408

Status
Completed
 
Locations

Investigative Site

Debowa Gora, Poland, 96-116

Status
Completed
 
Locations

Investigative Site

Kattowitz, Poland, 40-226

Status
Completed
 
Locations

Investigative Site

Kattowitz, Poland, 40-520

Status
Completed
 
Locations

Investigative Site

Albenga, Italy, 17031

Status
Completed
 
Locations

Investigative Site

Arenzano, Italy, 16011

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16125

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16149

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16161

Status
Completed
 
Locations

Investigative Site

Orbetello, Italy, 58100

Status
Completed
 
Locations

Investigative Site

Pegli, Italy, 16100

Status
Completed
 
Locations

Investigative Site

Quiliano, Italy, 17047

Status
Completed
 
Locations

Investigative Site

Rivarolo, Italy, 16150

Status
Completed
 
Locations

Investigative Site

Varazze, Italy, 17019

Status
Completed
 
Locations

Investigative Site

Krakau, Poland, 31-215

Status
Completed
 
Locations

Investigative Site

Piaseczno, Poland, 05-500

Status
Completed
 
Locations

Investigative Site

Skierniewice, Poland, 96-100

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 71-140

Status
Completed
 
Locations

Investigative Site

Thorn, Poland, 87-100

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 01-493

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 03-185

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 84101

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 84104

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 84107

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 85101

Status
Completed
 
Locations

Investigative Site

Kattowitz, Poland, 40-752

Status
Completed
 
Locations

Investigative Site

Lodzi, Poland, 93-105

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 71-502

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 01-961

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-091

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-793

Status
Completed
 
Locations

Investigative Site

Zabrze, Poland, 41-800

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 81107

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 85102

Status
Completed
 
Locations

Investigative Site

New York, United States, 11021

Status
Completed
 
Locations

Investigative Site

New York, United States, 11743

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 85105

Status
Completed
 
Locations

Investigative Site

Pezinok, Slovakia, 90201

Status
Completed
 
Locations

Investigative Site

Stupava, Slovakia, 90031

Status
Completed
 

Trial Design