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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aspirin; Lidocaine

Criteria

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