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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01265446
First received: December 20, 2010
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265446

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01265446     History of Changes
Other Study ID Numbers: 075-A-301, 2010-021653-39
Study First Received: December 20, 2010
Results First Received: March 29, 2012
Last Updated: April 17, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Common Cold
Pharyngitis
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Infection
Cetylpyridinium
Lidocaine
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013