Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 20, 2010
April 17, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ 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.
  • Change from baseline sore throat pain intensity up to 240 mn post-dose [ Time Frame: 240 mn post-dose ] [ Designated as safety issue: No ]
  • Change from baseline in sore throat pain relief up to 240 mn post-dose [ Time Frame: 240 mn post-dose ] [ Designated as safety issue: No ]
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: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01265446
075-A-301, 2010-021653-39
No
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