Effect of Paracetamol on the Common Cold

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01277081

First received: January 12, 2011

Last updated: July 26, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2011

Last Updated Date

July 26, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 15 minutes post dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01277081 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in Visual Rating Scale Scores for Other Cold Symptoms [ Time Frame: Baseline to 15 minutes post dose ] [ Designated as safety issue: No ]
Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 60 minutes post dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Paracetamol on the Common Cold

Official Title ^ICMJE

To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.

Brief Summary

The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Common Cold

Intervention ^ICMJE

Drug: Paracetamol hot drink
Hot drink containing paracetamol
Drug: Paracetamol tablets
Paracetamol tablets

Study Arm (s)

Active Comparator: Paracetamol hot drink
Hot drink containing paracetamol

Intervention: Drug: Paracetamol hot drink
Active Comparator: Paracetamol tablets
Paracetamol tablets

Intervention: Drug: Paracetamol tablets

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Symptoms of the common cold of no more than 120 hours duration
Self-rating congestion of at least moderate severity
Suffering from at least four symptoms of common cold or flu

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01277081

Other Study ID Numbers ^ICMJE

C7100991

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top