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Symptomatic Treatment of Common Cold Symptoms

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ClinicalTrials.gov Identifier: NCT01033526
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : December 16, 2009
Sponsor:
Information provided by:
Bayer

December 15, 2009
December 16, 2009
December 16, 2009
October 2005
Not Provided
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 ]
Same as current
No Changes Posted
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Adverse Event Collection [ Time Frame: Until end of study ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Common Cold
  • Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
    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
  • Drug: Placebo
    1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
  • Experimental: Arm 1
    Intervention: Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
Same as current
June 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01033526
11756
EudraCT: 2004-004683-71
No
Not Provided
Not Provided
Therapeutic Area Head, Bayer Consumer Care Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP