Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
Primary Purpose
Common Cold, Pharyngitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
Acetylsalicylic Acid (Aspirin, BAYE4465)
Pseudoephedrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Sore Throat, Upper Respiratory Tract Infections, Nasal Congestion
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
The primary efficacy parameter for sore throat was SPID2 hours
Secondary Outcome Measures
The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
The Nasal Congestion Score
The Nasal Congestion Relief Score
Sore throat pain relief
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
The results of an overall assessment of treatment by the subjects at 120 minutes post dose
The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug)
Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Total amount of drug intake
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01062360
Brief Title
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 23, 2005 (Actual)
Primary Completion Date
May 14, 2007 (Actual)
Study Completion Date
May 14, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Pharyngitis
Keywords
Sore Throat, Upper Respiratory Tract Infections, Nasal Congestion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1016 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
Time Frame
2 hours
Title
The primary efficacy parameter for sore throat was SPID2 hours
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
Time Frame
15, 30, 60, 90, 120, 240, and 360 minutes
Title
The Nasal Congestion Score
Time Frame
15, 30, 60, 90, 120, 240, and 360 minutes
Title
The Nasal Congestion Relief Score
Time Frame
15, 30, 60, 90, 120, 240, and 360 minutes
Title
Sore throat pain relief
Time Frame
15, 30, 60, 90, 120, 240, and 360 minutes
Title
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
Time Frame
120 minutes
Title
The results of an overall assessment of treatment by the subjects at 120 minutes post dose
Time Frame
120 minutes
Title
The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug)
Time Frame
Day 3
Title
Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Time Frame
Day 3
Title
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Time Frame
Day 2 and Day 3
Title
Total amount of drug intake
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
New York
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
11743
Country
United States
City
Alassio
ZIP/Postal Code
17021
Country
Italy
City
Albenga
ZIP/Postal Code
17031
Country
Italy
City
Arenzano
ZIP/Postal Code
16011
Country
Italy
City
Civitella Paganico
ZIP/Postal Code
58048
Country
Italy
City
Follonica
ZIP/Postal Code
58022
Country
Italy
City
Genova
ZIP/Postal Code
16010
Country
Italy
City
Genova
ZIP/Postal Code
16125
Country
Italy
City
Genova
ZIP/Postal Code
16128
Country
Italy
City
Genova
ZIP/Postal Code
16129
Country
Italy
City
Genova
ZIP/Postal Code
16131
Country
Italy
City
Genova
ZIP/Postal Code
16137
Country
Italy
City
Genova
ZIP/Postal Code
16143
Country
Italy
City
Genova
ZIP/Postal Code
16149
Country
Italy
City
Genova
ZIP/Postal Code
16161
Country
Italy
City
Genova
ZIP/Postal Code
16162
Country
Italy
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
City
Grossetto
ZIP/Postal Code
58100
Country
Italy
City
Isola del Cantone
ZIP/Postal Code
16017
Country
Italy
City
Loano
ZIP/Postal Code
17025
Country
Italy
City
Masone
ZIP/Postal Code
16010
Country
Italy
City
Orbetello
ZIP/Postal Code
58100
Country
Italy
City
Pegli
ZIP/Postal Code
16100
Country
Italy
City
Quiliano
ZIP/Postal Code
17047
Country
Italy
City
Rivarolo
ZIP/Postal Code
16150
Country
Italy
City
Ronco Scrivia
ZIP/Postal Code
16019
Country
Italy
City
Sampierdarena
ZIP/Postal Code
16151
Country
Italy
City
Scansano
ZIP/Postal Code
58054
Country
Italy
City
Serra Ricco
ZIP/Postal Code
16010
Country
Italy
City
Varazze
ZIP/Postal Code
17019
Country
Italy
City
Ciechocin
ZIP/Postal Code
87-408
Country
Poland
City
Debowa Gora
ZIP/Postal Code
96-116
Country
Poland
City
Kattowitz
ZIP/Postal Code
40-226
Country
Poland
City
Kattowitz
ZIP/Postal Code
40-520
Country
Poland
City
Kattowitz
ZIP/Postal Code
40-752
Country
Poland
City
Krakau
ZIP/Postal Code
31-215
Country
Poland
City
Lodzi
ZIP/Postal Code
93-105
Country
Poland
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
City
Szczecin
ZIP/Postal Code
71-140
Country
Poland
City
Szczecin
ZIP/Postal Code
71-502
Country
Poland
City
Thorn
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
01-493
Country
Poland
City
Warszawa
ZIP/Postal Code
01-961
Country
Poland
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
City
Warszawa
ZIP/Postal Code
03-185
Country
Poland
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
City
Bratislava
ZIP/Postal Code
81107
Country
Slovakia
City
Bratislava
ZIP/Postal Code
84101
Country
Slovakia
City
Bratislava
ZIP/Postal Code
84104
Country
Slovakia
City
Bratislava
ZIP/Postal Code
84107
Country
Slovakia
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
City
Bratislava
ZIP/Postal Code
85102
Country
Slovakia
City
Bratislava
ZIP/Postal Code
85105
Country
Slovakia
City
Pezinok
ZIP/Postal Code
90201
Country
Slovakia
City
Stupava
ZIP/Postal Code
90031
Country
Slovakia
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
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