Symptomatic Treatment of Common Cold Symptoms

December 15, 2009 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Albano Sant'Alessandro, Italy, 24061
      • Varese, Italy, 21100
    • Bergamo
      • 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
    • Varese
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Placebo Comparator: Arm 2
Drug: Placebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hours following intake of the first study medication dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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
Until end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

December 16, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11756
  • EudraCT: 2004-004683-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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