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

EU CT 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
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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
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Locations

Investigative Site

Moscow, Russia, 117393

Locations

Investigative Site

Moscow, Russia, 117513

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Investigative Site

Moscow, Russia, 114765

Locations

Investigative Site

Moscow, Russia, 117418

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Investigative Site

Mocow, Russia, 117574

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Investigative Site

Moscow, Russia, 117342

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Investigative Site

Moscow, Russia, 117485

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Investigative Site

Moscow, Russia, 117321

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Investigative Site

Moscow, Russia, 117588

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Investigative Site

Moscow, Russia, 117421

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Investigative Site

Moscow, Russia, 127299

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Investigative Site

Moscow, Russia, 105064

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Investigative Site

Novosibirsk, Russia, 630099

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Investigative Site

Kiev, Ukraine, 02222

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Investigative Site

Kiev, Ukraine, 02091

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Investigative Site

Lugansk, Ukraine, 91011

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Investigative Site

Lugansk, Ukraine, 91055

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Investigative Site

Kiev, Ukraine, 02232

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Investigative Site

Kiev, Ukraine, 03049

Trial Design