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

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.

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.

Study Overview

• Status: Completed
• Conditions: Common Cold; Tonsillitis; Pharyngitis
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Lidocain; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1088
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Mocow, Russian Federation, 117574
  • Moscow, Russian Federation, 127299
  • Moscow, Russian Federation, 105064
  • Moscow, Russian Federation, 117485
  • Moscow, Russian Federation, 114765
  • Moscow, Russian Federation, 117321
  • Moscow, Russian Federation, 117342
  • Moscow, Russian Federation, 117393
  • Moscow, Russian Federation, 117418
  • Moscow, Russian Federation, 117421
  • Moscow, Russian Federation, 117513
  • Moscow, Russian Federation, 117588
  • Novosibirsk, Russian Federation, 630099
• Ukraine
  • Kiev, Ukraine, 03049
  • Kiev, Ukraine, 02091
  • Kiev, Ukraine, 02232
  • Kiev, Ukraine, 02222
  • Lugansk, Ukraine, 91011
  • Lugansk, Ukraine, 91055

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer; Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2004
• Primary Completion (Actual): May 28, 2005
• Study Completion (Actual): May 28, 2005

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimated): May 26, 2011

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Sore Throat
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; Common Cold; Tonsillitis; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Aspirin; Lidocaine
• Other Study ID Numbers: 11640