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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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.

NCT01361399•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (19)

Mocow, Russia

Moscow, Russia

Key Dates

Start Date

November 30, 2004

Primary Completion Date

May 28, 2005

Completion Date

May 28, 2005

Last Updated

October 18, 2023

Enrollment

1,088

ACTUAL participants

Conditions

Common ColdPharyngitisTonsillitis

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

DRUG

Lidocain

DRUG

Placebo

DRUG

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT06326983

TonsillitisPost-operative Nausea and Vomiting (PONV)+4 more

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RECRUITINGNA

Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics

NCT06370208

Streptococcus Pyogenes Pharyngotonsillitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics

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