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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265446
First Posted: December 23, 2010
Last Update Posted: April 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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.

Condition Intervention Phase
Sore Throat Due to a Common Cold Drug: Lidocaine 8mg + CPC 2mg Drug: Lidocaine 1mg + CPC 2mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 250
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine 8mg +CPC 2mg
one single dose
Drug: Lidocaine 8mg + CPC 2mg
one single dose
Active Comparator: Lidocaine 1mg + CPC 2mg
one single dose
Drug: Lidocaine 1mg + CPC 2mg
one single dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265446


Locations
Germany
Socratec
Erfurt, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Investigator SocraTec R&D GmbH
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01265446     History of Changes
Other Study ID Numbers: 075-A-301
2010-021653-39 ( EudraCT Number )
First Submitted: December 20, 2010
First Posted: December 23, 2010
Results First Submitted: March 29, 2012
Results First Posted: July 26, 2012
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Novartis:
Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Pharyngitis
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Lidocaine
Cetylpyridinium
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents