Back to resultsSymptomatic Treatment of Common Cold Symptoms
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Aspirin (Acetylsalicylic acid, BAYE4465)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Symptomatic treatment of Common Cold symptoms
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years
- Onset of cold symptoms within 48 hours before screening
- Objective symptoms of common cold
- Subjective symptoms of common cold
Exclusion Criteria:
- Pregnancy or lactation period
- Active peptic ulcer
- Hemorrhagic diathesis
- History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
- Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm 2
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
Secondary Outcome Measures
Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
Changes in Global Cold Severity (WURSS domain 1)
Changes in Cold Symptoms (WURSS domain 2)
Changes in Cold-specific Functional Impairments (WURSS domain 3)
Changes in Global Cold Severity (WURSS domain 4)
Adverse Event Collection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01033526
Brief Title
Symptomatic Treatment of Common Cold Symptoms
Official Title
A Two-arm, Multicenter, Randomized, Double-blind, Single Dose Placebo-controlled Parallel Groups Study Evaluating Efficacy and Tolerability of 800 mg Acetylsalicylic Acid (Aspirina® C) in Adult Patients With a Common Cold During a Two Hour in Patient Phase; and a Follow-up Period of Five Days of Home Treatment as Required
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Symptomatic treatment of Common Cold symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aspirin (Acetylsalicylic acid, BAYE4465)
Intervention Description
1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Primary Outcome Measure Information:
Title
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
Time Frame
2 hours following intake of the first study medication dose
Secondary Outcome Measure Information:
Title
Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
Time Frame
At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)
Title
Changes in Global Cold Severity (WURSS domain 1)
Time Frame
At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)
Title
Changes in Cold Symptoms (WURSS domain 2)
Time Frame
At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)
Title
Changes in Cold-specific Functional Impairments (WURSS domain 3)
Time Frame
At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)
Title
Changes in Global Cold Severity (WURSS domain 4)
Time Frame
At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period)
Title
Adverse Event Collection
Time Frame
Until end of study
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:
Age between 18 and 65 years
Onset of cold symptoms within 48 hours before screening
Objective symptoms of common cold
Subjective symptoms of common cold
Exclusion Criteria:
Pregnancy or lactation period
Active peptic ulcer
Hemorrhagic diathesis
History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Borgo Di Terzo
State/Province
Bergamo
ZIP/Postal Code
24060
Country
Italy
City
Brembate
State/Province
Bergamo
ZIP/Postal Code
24041
Country
Italy
City
Calusco d'Adda
State/Province
Bergamo
ZIP/Postal Code
24033
Country
Italy
City
Capriate San Gervasio
State/Province
Bergamo
ZIP/Postal Code
24042
Country
Italy
City
Caravaggio
State/Province
Bergamo
ZIP/Postal Code
24043
Country
Italy
City
Casazza
State/Province
Bergamo
ZIP/Postal Code
24060
Country
Italy
City
Cologno Al Serio
State/Province
Bergamo
ZIP/Postal Code
24055
Country
Italy
City
Covo
State/Province
Bergamo
ZIP/Postal Code
24050
Country
Italy
City
Dalmine
State/Province
Bergamo
ZIP/Postal Code
24044
Country
Italy
City
Mozzanica
State/Province
Bergamo
ZIP/Postal Code
24050
Country
Italy
City
Ponte San Pietro
State/Province
Bergamo
ZIP/Postal Code
24036
Country
Italy
City
Seriate
State/Province
Bergamo
ZIP/Postal Code
24068
Country
Italy
City
Verdello
State/Province
Bergamo
ZIP/Postal Code
24049
Country
Italy
City
Vertova
State/Province
Bergamo
ZIP/Postal Code
24029
Country
Italy
City
Villa d'Adda
State/Province
Bergamo
ZIP/Postal Code
24030
Country
Italy
City
Angera
State/Province
Varese
ZIP/Postal Code
21021
Country
Italy
City
Carnago
State/Province
Varese
ZIP/Postal Code
21040
Country
Italy
City
Cavaria
State/Province
Varese
ZIP/Postal Code
21044
Country
Italy
City
Comerio
State/Province
Varese
ZIP/Postal Code
21025
Country
Italy
City
Cunardo
State/Province
Varese
ZIP/Postal Code
21035
Country
Italy
City
Fagnano Olona
State/Province
Varese
ZIP/Postal Code
21054
Country
Italy
City
Induno Olona
State/Province
Varese
ZIP/Postal Code
21056
Country
Italy
City
Sesto Calende
State/Province
Varese
ZIP/Postal Code
21018
Country
Italy
City
Solbiate Olona
State/Province
Varese
ZIP/Postal Code
21058
Country
Italy
City
Vedano Olona
State/Province
Varese
ZIP/Postal Code
21040
Country
Italy
City
Vergiate
State/Province
Varese
ZIP/Postal Code
21029
Country
Italy
City
Albano Sant'Alessandro
ZIP/Postal Code
24061
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Symptomatic Treatment of Common Cold Symptoms
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