Symptomatic Treatment of Common Cold Symptoms

Phase 4

Completed

• Conditions: Common Cold
• Interventions: Drug: Placebo; Drug: Aspirin (Acetylsalicylic acid, BAYE4465)

• Registration Number: NCT01033526
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Study Completion: 2007-06
• Status Verified: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Last Update Submitted: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Posted: 2009-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Aspirin (Acetylsalicylic acid, BAYE4465)	-

Primary Outcome Measures

Name	Time	Method
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline	2 hours following intake of the first study medication dose

Secondary Outcome Measures

Name	Time	Method
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