Symptomatic Treatment of Common Cold Symptoms

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Interventions

  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Arm 2
  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary 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

Secondary 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)
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Therapeutic Area Head, Bayer Consumer Care Inc.
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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