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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1088 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Common Cold Pharyngitis Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

Intervention Type DRUG

Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)

Arm 2

Group Type ACTIVE_COMPARATOR

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Single oral application of Aspirin (as lozenge)

Arm 3

Group Type ACTIVE_COMPARATOR

Lidocain

Intervention Type DRUG

Single oral application of Lidocain (as lozenge)

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single oral application of Placebo (as lozenge)

Interventions

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Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)

Intervention Type DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

Single oral application of Aspirin (as lozenge)

Intervention Type DRUG

Lidocain

Single oral application of Lidocain (as lozenge)

Intervention Type DRUG

Placebo

Single oral application of Placebo (as lozenge)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No