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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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 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 |
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)
|
- Sum of pain intensity differences SPID [ Time Frame: 120 minutes ]
- Pain intensity difference to baseline (PID12 min) [ Time Frame: 12 minutes ]
- Pain intensity difference to baseline (PID120 min) [ Time Frame: 120 minutes ]
- 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 ]
- 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 ]
- Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain) [ Time Frame: 60, 120, 180, and 240 minutes post dose ]
- Overall assessment of treatment [ Time Frame: 240 minutes ]
- Assessment of safety and tolerability [ Time Frame: 240 minutes ]

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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

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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Study Director: | Bayer Study Director | Bayer |
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 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 |