MedTrace Logo

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

NCT01361399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1088

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Common Cold
  • Pharyngitis
  • Tonsillitis

Interventions

DRUG

Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

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

DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

Single oral application of Aspirin (as lozenge)

DRUG

Lidocain

Single oral application of Lidocain (as lozenge)

DRUG

Placebo

Single oral application of Placebo (as lozenge)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-05-28
Completion
2005-05-28

Countries

  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361399 on ClinicalTrials.gov