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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
December 20, 2010
December 23, 2010
March 29, 2012
July 26, 2012
April 24, 2013
December 2010
April 2011   (Final data collection date for primary outcome measure)
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)
Change from baseline sore throat intensity [ Time Frame: 2 hours post-dose ]
Complete list of historical versions of study NCT01265446 on ClinicalTrials.gov Archive Site
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.
  • Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose [ Time Frame: 240 mn post-dose ]
  • Change from baseline in sore throat pain relief up to 240 mn post-dose [ Time Frame: 240 mn post-dose ]
Not Provided
Not Provided
 
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sore Throat Due to a Common Cold
  • Drug: Lidocaine 8mg + CPC 2mg
    one single dose
  • Drug: Lidocaine 1mg + CPC 2mg
    one single dose
  • Experimental: Lidocaine 8mg +CPC 2mg
    one single dose
    Intervention: Drug: Lidocaine 8mg + CPC 2mg
  • Active Comparator: Lidocaine 1mg + CPC 2mg
    one single dose
    Intervention: Drug: Lidocaine 1mg + CPC 2mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01265446
075-A-301
2010-021653-39 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Principal Investigator: Investigator SocraTec R&D GmbH
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP