NCT01033526
Completed
Phase 4
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
ConditionsCommon Cold
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Common Cold
- Sponsor
- Bayer
- Enrollment
- 388
- Primary Endpoint
- Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Arms & Interventions
Arm 2
Intervention: Placebo
Arm 1
Intervention: Aspirin (Acetylsalicylic acid, BAYE4465)
Outcomes
Primary Outcomes
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 Outcomes
- Changes in Common Cold Profile (sum of WURSS domains 1 182 3)(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)(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)(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)(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)(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(Until end of study)
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