Clinical Trial: Symptomatic Treatment of Common Cold Symptoms
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 P
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 Summary:
Sponsor: Bayer
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: December 15, 2009
Date Started: October 2005
Date Completion:
Last Updated: December 15, 2009
Last Verified: December 2009