Trial Condition(s):

Common Cold, Pharyngitis, Tonsillitis

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

Bayer Identifier:

11640

ClinicalTrials.gov Identifier:

NCT01361399

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
1088
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Moscow, Russia, 117393

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117513

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 114765

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117418

Status
Completed
 
Locations

Investigative Site

Mocow, Russia, 117574

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117342

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117485

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117321

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117588

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117421

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 127299

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 105064

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630099

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02222

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02091

Status
Completed
 
Locations

Investigative Site

Lugansk, Ukraine, 91011

Status
Completed
 
Locations

Investigative Site

Lugansk, Ukraine, 91055

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02232

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 03049

Status
Completed
 

Trial Design