Phase 2 N=200 Randomized Treatment

Effect of Paracetamol on the Common Cold

Common Cold

Bottom Line

View on ClinicalTrials.gov: NCT01277081 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Breathing Scores Post 15 Minutes — 0.83; 0.11 Score on a Scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Paracetamol hot drink (Drug); Paracetamol tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Breathing Scores Post 15 Minutes	0.83; 0.11	<0.0001 sig
SECONDARY Breathing Score Post 60 Minutes	0.92; 0.34	<0.0001 sig
SECONDARY Cold Symptoms Score Post 15 Minutes	0.64; 0.13	<0.0001 sig
SECONDARY Cold Symptoms Score Post 60 Minutes	0.87; 0.35	<0.0001 sig
SECONDARY Soothing Attribute Scores	2.3; 1.2; 2.4; 1.3	—
SECONDARY Overall Cold Symptoms Score	1.8; 0.9; 2.1; 1.3	—

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

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01277081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.