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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.

Official Title
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A 4-arm, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Single Dose, Parallel Group Study Comparing Efficacy and Safety of a Fixed Combination of 500 mg Acetylsalicylic Acid + 4 mg Lidocaine With 500 mg Acetylsalicylic Acid and 4 mg Lidocaine Monotherapy as Well as Placebo in Adult Patients With Sore Throat Associated With a Common Cold.

Conditions
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Common Cold, Pharyngitis, Tonsillitis

Intervention / Treatment
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* Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
* Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
* Drug: Lidocain
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain Findings that confirmed the presence of tonsillopharyngitis Exclusion Criteria: Pregnancy (i.e. positive pregnancy test at baseline) Breastfeeding History of hypersensitivity (allergic reaction) to ASA or any other NSAID History of hypersensitivity (allergic reaction) to lidocaine History or acute state of peptic ulceration or gastrointestinal bleeding History of bleeding tendency History of asthma Clinical diagnosis of chickenpox or influenza History or presence of severe liver or kidney disease Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours Use of any local or systemic short-acting cough and cold preparation (e.g. decongestant or antihistaminic drug) in the last 12 hours Use of any cough or sore throat lozenges/candies or any menthol-containing product (including mentholated tissues) in the last 6 hours Current intake or requirement of any prescription medication for the current treatment of acute respiratory tract illness Administration of anticoagulants in the last 7 days Inability to breathe through the nose or a history of chronic mouth breathing Presence of any severe concomitant disease or condition which, in the opinion of the investigator, is a reason for exclusion, e.g. serious cardiovascular diseases (in particular arrhythmias), treatment with antiarrhythmics or methotrexate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain<br>* Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)<br>|
| Active Comparator: Arm 2<br> | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Single oral application of Aspirin (as lozenge)<br>|
| Active Comparator: Arm 3<br> | Drug: Lidocain<br>* Single oral application of Lidocain (as lozenge)<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Single oral application of Placebo (as lozenge)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall assessment of treatment |  | 240 minutes | 
| Assessment of safety and tolerability |  | 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sore Throat