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 Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Common Cold; Pharyngitis; Tonsillitis	Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Lidocain; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1088 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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.
Study Start Date :	November 2004
Actual Study Completion Date :	May 2005

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Sum of pain intensity differences SPID [ Time Frame: 120 minutes ]
2. Pain intensity difference to baseline (PID12 min) [ Time Frame: 12 minutes ]
3. Pain intensity difference to baseline (PID120 min) [ Time Frame: 120 minutes ]

Secondary Outcome Measures :

1. Pain intensity difference to baseline (PID) [ Time Frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose ]
2. Total pain relief to baseline (TOTPAR) [ Time Frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose ]
3. Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain) [ Time Frame: 60, 120, 180, and 240 minutes post dose ]
4. Overall assessment of treatment [ Time Frame: 240 minutes ]
5. Assessment of safety and tolerability [ Time Frame: 240 minutes ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Russian Federation
ask Contact, Russian Federation
Ukraine
ask Contact, Ukraine

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

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Responsible Party:	Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier:	NCT01361399 History of Changes
Other Study ID Numbers:	11640
First Posted:	May 26, 2011
Last Update Posted:	May 26, 2011
Last Verified:	May 2011

Keywords provided by Bayer:

Sore Throat

Additional relevant MeSH terms:

Common Cold; Pharyngitis; Tonsillitis; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Lidocaine; Aspirin; Anesthetics, Local; Anesthetics

Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents