Symptomatic Treatment of Common Cold Symptoms
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
2 other identifiers
interventional
388
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedDecember 16, 2009
December 1, 2009
December 15, 2009
December 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
2 hours following intake of the first study medication dose
Secondary Outcomes (6)
Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
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)
Changes in Global Cold Severity (WURSS domain 1)
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)
Changes in Cold Symptoms (WURSS domain 2)
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)
Changes in Cold-specific Functional Impairments (WURSS domain 3)
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)
Changes in Global Cold Severity (WURSS domain 4)
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)
- +1 more secondary outcomes
Study Arms (2)
Arm 2
PLACEBO COMPARATORArm 1
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (28)
Unknown Facility
Borgo di Terzo, Bergamo, 24060, Italy
Unknown Facility
Brembate, Bergamo, 24041, Italy
Unknown Facility
Calusco d'Adda, Bergamo, 24033, Italy
Unknown Facility
Capriate San Gervasio, Bergamo, 24042, Italy
Unknown Facility
Caravaggio, Bergamo, 24043, Italy
Unknown Facility
Casazza, Bergamo, 24060, Italy
Unknown Facility
Cologno al Serio, Bergamo, 24055, Italy
Unknown Facility
Covo, Bergamo, 24050, Italy
Unknown Facility
Dalmine, Bergamo, 24044, Italy
Unknown Facility
Mozzanica, Bergamo, 24050, Italy
Unknown Facility
Ponte San Pietro, Bergamo, 24036, Italy
Unknown Facility
Seriate, Bergamo, 24068, Italy
Unknown Facility
Verdello, Bergamo, 24049, Italy
Unknown Facility
Vertova, Bergamo, 24029, Italy
Unknown Facility
Villa d'Adda, Bergamo, 24030, Italy
Unknown Facility
Angera, Varese, 21021, Italy
Unknown Facility
Carnago, Varese, 21040, Italy
Unknown Facility
Cavaria, Varese, 21044, Italy
Unknown Facility
Comerio, Varese, 21025, Italy
Unknown Facility
Cunardo, Varese, 21035, Italy
Unknown Facility
Fagnano Olona, Varese, 21054, Italy
Unknown Facility
Induno Olona, Varese, 21056, Italy
Unknown Facility
Sesto Calende, Varese, 21018, Italy
Unknown Facility
Solbiate Olona, Varese, 21058, Italy
Unknown Facility
Varese, Varese, 21100, Italy
Unknown Facility
Vedano Olona, Varese, 21040, Italy
Unknown Facility
Vergiate, Varese, 21029, Italy
Unknown Facility
Albano Sant'Alessandro, 24061, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
October 1, 2005
Study Completion
June 1, 2007
Last Updated
December 16, 2009
Record last verified: 2009-12