Status:

COMPLETED

Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.

Lead Sponsor:

Novartis

Conditions:

Sore Throat Due to a Common Cold

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 trea...

Eligibility Criteria

Inclusion

  • 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

  • \- 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

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2011

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT01265446

Start Date

December 1 2010

End Date

April 1 2011

Last Update

April 24 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Socratec

Erfurt, Germany