Symptomatic Treatment of Common Cold Symptoms

Common Cold Clinical Trial

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 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033526
• Other study ID #: 11756
• Secondary ID: EudraCT: 2004-00
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2009
• Last updated: December 15, 2009
• Start date: October 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

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
• Placebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Adverse Event Collection		Until end of study	Yes

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