Trial Condition(s):
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
11640
Not Available
Not Available
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.
- 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
- 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
Locations | Status | |
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Locations Investigative Site Moscow, Russia, 117393 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117513 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 114765 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117418 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mocow, Russia, 117574 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117342 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117485 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117588 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 127299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 105064 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novosibirsk, Russia, 630099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02222 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lugansk, Ukraine, 91011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lugansk, Ukraine, 91055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 03049 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4