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Lidocaine+ CPC

Phase 3

Sore Throat Due to a Common Cold | Small molecule | ENT |Novartis AG|Last Updated: Apr 24, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

Lidocaine+ CPC · 1 trial · 1 indication

Phase 3 1
NCT01265446Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.Sore Throat Due to a Common Cold
COMPLETED250 Analytics
PHASE3COMPLETED
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
Sore Throat Due to a Common Cold
NCT01265446250
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Study Endpoints

Primary Endpoints

Change From Baseline Sore Throat Pain Intensity
Baseline and 2 hours post-dose

100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)

Secondary Endpoints

Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose
Baseline and 240 mn post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lidocaine 8mg +CPC 2mgEXPERIMENTALone single dose
Lidocaine 1mg + CPC 2mgACTIVE_COMPARATORone single dose

Interventions

NameTypeDescription
Lidocaine 8mg + CPC 2mgDRUGone single dose
Lidocaine 1mg + CPC 2mgDRUGone single dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 si...

Countries:Germany
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