MedDataX Logo

Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

NCT ID: NCT00963443

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

833 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Common Cold

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Aspirin Complex Acetylsalicylic Acid Pseudoephedrine Common Cold

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

2 Sachets of 500 mg Aspirin Complex.

Pseudoephedrine

Intervention Type DRUG

2 Sachets of 30 mg Pseudoephedrine

Arm 2

Group Type ACTIVE_COMPARATOR

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

2 Sachets of 500 mg Aspirin Complex.

Arm 3

Group Type ACTIVE_COMPARATOR

Pseudoephedrine

Intervention Type DRUG

2 Sachets of 30 mg Pseudoephedrine

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetylsalicylic Acid (Aspirin, BAYE4465)

2 Sachets of 500 mg Aspirin Complex.

Intervention Type DRUG

Pseudoephedrine

2 Sachets of 30 mg Pseudoephedrine

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiff, South Glamorgan, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.clinicaltrialsregister.eu

Click here and search for EMA Websynopsis results

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-011355-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13700

Identifier Type: -

Identifier Source: org_study_id