Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

Common Cold Clinical Trial

Official title:

A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963443
• Other study ID #: 13700
• Secondary ID: 2009-011355-46
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2009
• Last updated: December 4, 2014
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion Criteria:

• < 18 years old

Study Design

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin, BAYE4465)
2 Sachets of 500 mg Aspirin Complex.
• Pseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
• Placebo
Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of nasal congestion and relief of pain		4 hours	No
Secondary	Area under the curve for nasal airflow conductance from baseline		1h, 2h, 3h	No
Secondary	Sum of subjective nasal congestion intensity differences		1h, 2h, 3h, 4h and 1, 2, 3 days	No
Secondary	Total subjective nasal congestion relief		1h, 2h, 3h,4 h and 1, 2, 3 days	No
Secondary	Global assessment of nasal congestion		3 days	No
Secondary	Global assessment of pain relief		3 days	No
Secondary	Sum of pain intensity differences		1h, 2h, 3h, 4h and 1, 2, 3 days	No
Secondary	Total pain relief		1, 2, 3 days	No
Secondary	Adverse Event collection and physical examination		3 days	Yes

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