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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