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OpenTrials
Completed

NCT Number: NCT01265446

Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.

This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.

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Key information

Conditions

Sore Throat Due to a Common Cold Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Socratec

Erfurt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
  • Sore throat of at least moderate pain intensity

Exclusion criteria

  • - History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
  • Evidence of mouth breathing or severe coughing
  • Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
  • Severe renal, liver or cardiac impairment
  • Severe lung disease

Treatment and study plan

Lidocaine 8mg + CPC 2mg

Drug

one single dose

Lidocaine 1mg + CPC 2mg

Drug

one single dose

Primary outcomes

  1. Change From Baseline Sore Throat Pain Intensity

    Time frame: Baseline and 2 hours post-dose

    100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)

Secondary outcomes

  1. Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose

    Time frame: Baseline and 240 mn post-dose

    100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel Group, Single-dose Study of the Efficacy of Lidocaine 8 mg + Cetylpyridinium Chloride (CPC) 2 mg Fixed Combination Lozenges on Sore Throat Pain Intensity Compared to Lozenges Containing Lidocaine 1 mg and CPC 2 mg in Subjects With Sore Throat Due to Upper Respiratory Tract Infection.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2010
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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