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

• ClinicalTrials.gov Identifier: NCT01361399
• Recruitment Status: Completed
• First Posted: May 26, 2011
• Last Update Posted: May 26, 2011
• Sponsor: Bayer
• Information provided by: Bayer

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

Russian Federation

ask Contact, Russian Federation

Ukraine

ask Contact, Ukraine

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• 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; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Aspirin; Lidocaine; 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