Clinical trial NCT01033526: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Keywords: Symptomatic treatment of Common Cold symptoms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
timeFrame: 2 hours following intake of the first study medication dose
Secondary outcomes:
measure: Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
timeFrame: 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)
measure: Changes in Global Cold Severity (WURSS domain 1)
timeFrame: 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)
measure: Changes in Cold Symptoms (WURSS domain 2)
timeFrame: 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)
measure: Changes in Cold-specific Functional Impairments (WURSS domain 3)
timeFrame: 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)
measure: Changes in Global Cold Severity (WURSS domain 4)
timeFrame: 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)
measure: Adverse Event Collection
timeFrame: Until end of study
Other outcomes:
Locations:
city: Borgo Di Terzo
country: Italy
state: Bergamo
city: Brembate
country: Italy
state: Bergamo
city: Calusco d'Adda
country: Italy
state: Bergamo
city: Capriate San Gervasio
country: Italy
state: Bergamo
city: Caravaggio
country: Italy
state: Bergamo
city: Casazza
country: Italy
state: Bergamo
city: Cologno Al Serio
country: Italy
state: Bergamo
city: Covo
country: Italy
state: Bergamo
city: Dalmine
country: Italy
state: Bergamo
city: Mozzanica
country: Italy
state: Bergamo
city: Ponte San Pietro
country: Italy
state: Bergamo
city: Seriate
country: Italy
state: Bergamo
city: Verdello
country: Italy
state: Bergamo
city: Vertova
country: Italy
state: Bergamo
city: Villa d'Adda
country: Italy
state: Bergamo
city: Angera
country: Italy
state: Varese
city: Carnago
country: Italy
state: Varese
city: Cavaria
country: Italy
state: Varese
city: Comerio
country: Italy
state: Varese
city: Cunardo
country: Italy
state: Varese
city: Fagnano Olona
country: Italy
state: Varese
city: Induno Olona
country: Italy
state: Varese
city: Sesto Calende
country: Italy
state: Varese
city: Solbiate Olona
country: Italy
state: Varese
city: Vedano Olona
country: Italy
state: Varese
city: Vergiate
country: Italy
state: Varese
city: Albano Sant'Alessandro
country: Italy
city: Varese
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: