check_circleStudy Completed

Common Cold

Bayer Identifier:

11756

ClinicalTrials.gov Identifier:

NCT01033526

EudraCT Number:

Not Available

EU CT Number:

Not Available
Symptomatic treatment of common cold symptoms

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
388
Trial Dates
October 2005 - June 2007
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
ASL Prov Varese - LombardiaVarese, 21100, Italy
Completed
Ambulatorio Dr Mauro PigniFagnano Olona, 21054, Italy
Completed
Ambulatorio Dr. Maurizio ViganòVergiate, 21029, Italy
Completed
Ambulatorio Dr. Claudio BullaCapriate San Gervasio, 24042, Italy
Completed
Ambulatorio Dr. Luigi DonzelliVerdello, 24049, Italy
Completed
Ambulatorio Dr. Alessandro FilippiMozzanica, 24050, Italy
Completed
Ambulatorio Dr Raimondo GiulianaBrembate, 24041, Italy
Completed
Ambulatorio Dr Sergio NicoliBorgo di Terzo, 24060, Italy
Completed
Ambulatorio Dr. Marina PezzanoCovo, 24050, Italy
Completed
Ambulatorio Dr. Paola PiniSeriate, 24068, Italy
Completed
Ambulatorio Dr Francesco RizzaCologno al Serio, 24055, Italy
Completed
Ambulatorio Dr Manuela MariuzDalmine, 24044, Italy
Completed
Fagnano Olona, 21054, Italy
Completed
Calusco d'Adda, 24033, Italy
Completed
Cavaria, 21044, Italy
Completed
Cunardo, 21035, Italy
Completed
Ambulatorio Dr. Mauro CalzolariVedano Olona, 21040, Italy
Completed
Ambulatorio Dr. Valter ColomboSolbiate Olona, 21058, Italy
Completed
Ambulatorio Dr Marco PassamontiFagnano Olona, 21054, Italy
Completed
Ambulatorio Dr. Vincenzo SpadaInduno Olona, 21056, Italy
Completed
Ambulatorio Dr. Ettore MantioneCologno al Serio, 24055, Italy
Completed
Ambulatorio Dr. Claudio MascarettiCaravaggio, 24043, Italy
Completed
Ambulatorio Dr. Fabio VillaVilla d'Adda, 24030, Italy
Completed
Ambulatorio Dr. Mario ZappaCasazza, 24060, Italy
Completed
Angera, 21021, Italy
Completed
Sesto Calende, 21018, Italy
Completed
Fagnano Olona, 21054, Italy
Completed
Comerio, 21025, Italy
Completed
Carnago, 21040, Italy
Completed
Ponte San Pietro, 24036, Italy
Completed
Vertova, 24029, Italy
Completed
Albano Sant'Alessandro, 24061, Italy

Primary Outcome

  • Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
    date_rangeTime Frame:
    2 hours following intake of the first study medication dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    no
  • Changes in Global Cold Severity (WURSS domain 1)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    no
  • Changes in Cold Symptoms (WURSS domain 2)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    no
  • Changes in Cold-specific Functional Impairments (WURSS domain 3)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    no
  • Changes in Global Cold Severity (WURSS domain 4)
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event Collection
    date_rangeTime Frame:
    Until end of study
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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 Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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