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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014