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Acetylsalicylic acid & Lidocain

Phase 3

Common Cold | Small molecule | Infectious Disease |Bayer AG|Last Updated: Oct 18, 2023

Target and mechanism

ModalitySmall molecule

Also known as Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,088

FDA Designations

No designations recorded

Clinical trial landscape

Acetylsalicylic acid & Lidocain · 1 trial · 3 indications

Phase 3 1
NCT01361399Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common ColdCommon Cold
COMPLETED1,088 Analytics
PHASE3COMPLETED
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold
Common Cold
NCT013613991,088
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Study Endpoints

Primary Endpoints

Sum of pain intensity differences SPID
120 minutes
Pain intensity difference to baseline (PID12 min)
12 minutes
Pain intensity difference to baseline (PID120 min)
120 minutes

Secondary Endpoints

Pain intensity difference to baseline (PID)
3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Total pain relief to baseline (TOTPAR)
3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
60, 120, 180, and 240 minutes post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -
Arm 4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Acetylsalicylic acid (Aspirin, BAYE4465) & LidocainDRUGSingle oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
Acetylsalicylic Acid (Aspirin, BAYE4465)DRUGSingle oral application of Aspirin (as lozenge)
LidocainDRUGSingle oral application of Lidocain (as lozenge)
PlaceboDRUGSingle oral application of Placebo (as lozenge)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Males and females of at least 18 years of age * Onset of common cold within the last 3 days (12 to 72 hours) * History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullne...

Countries:RussiaUkraine
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