Symptomatic Treatment of Common Cold Symptoms

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01033526
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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.


Condition Intervention Phase
Common Cold
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Adverse Event Collection [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]

Enrollment: 388
Study Start Date: October 2005
Study Completion Date: June 2007
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: Placebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Experimental: Arm 1 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033526

Locations
Italy
Borgo Di Terzo, Bergamo, Italy, 24060
Brembate, Bergamo, Italy, 24041
Calusco d'Adda, Bergamo, Italy, 24033
Capriate San Gervasio, Bergamo, Italy, 24042
Caravaggio, Bergamo, Italy, 24043
Casazza, Bergamo, Italy, 24060
Cologno Al Serio, Bergamo, Italy, 24055
Covo, Bergamo, Italy, 24050
Dalmine, Bergamo, Italy, 24044
Mozzanica, Bergamo, Italy, 24050
Ponte San Pietro, Bergamo, Italy, 24036
Seriate, Bergamo, Italy, 24068
Verdello, Bergamo, Italy, 24049
Vertova, Bergamo, Italy, 24029
Villa d'Adda, Bergamo, Italy, 24030
Angera, Varese, Italy, 21021
Carnago, Varese, Italy, 21040
Cavaria, Varese, Italy, 21044
Comerio, Varese, Italy, 21025
Cunardo, Varese, Italy, 21035
Fagnano Olona, Varese, Italy, 21054
Induno Olona, Varese, Italy, 21056
Sesto Calende, Varese, Italy, 21018
Solbiate Olona, Varese, Italy, 21058
Vedano Olona, Varese, Italy, 21040
Vergiate, Varese, Italy, 21029
Albano Sant'Alessandro, Italy, 24061
Varese, Italy, 21100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT01033526     History of Changes
Other Study ID Numbers: 11756, EudraCT: 2004-004683-71
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Bayer:
Symptomatic treatment of Common Cold symptoms

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014