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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
  Purpose

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


Condition Intervention Phase
Common Cold
 Drug: Paracetamol hot drink
Drug: Paracetamol tablets
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paracetamol hot drink
Hot drink containing paracetamol
 Drug: Paracetamol hot drink
Hot drink containing paracetamol
Active Comparator: Paracetamol tablets
Paracetamol tablets
 Drug: Paracetamol tablets
Paracetamol tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277081

Locations
United Kingdom
Common Cold Centre
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277081     History of Changes
Other Study ID Numbers: C7100991
Study First Received: January 12, 2011
Last Updated: July 26, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Paracetamol
Common cold

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Acetaminophen
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013