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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

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ClinicalTrials.gov Identifier: NCT01361399
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
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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
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361399

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
More Information

Additional 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    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011

Keywords provided by Bayer:
Sore Throat

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Anesthetics, Local
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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents