Common Cold, Pharyngitis, Tonsillitis
Conditions
Keywords
Sore Throat
Brief 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.
Interventions
DRUGAcetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
Single oral application of Aspirin (as lozenge)
DRUGLidocain
Single oral application of Lidocain (as lozenge)
DRUGPlacebo
Single oral application of Placebo (as lozenge)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of pain intensity differences SPID | 120 minutes |
| Pain intensity difference to baseline (PID12 min) | 12 minutes |
| Pain intensity difference to baseline (PID120 min) | 120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Overall assessment of treatment | 240 minutes |
| Pain intensity difference to baseline (PID) | 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose |
| Assessment of safety and tolerability | 240 minutes |
| Total pain relief to baseline (TOTPAR) | 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose |
| Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain) | 60, 120, 180, and 240 minutes post dose |
Countries
Russia, Ukraine
Outcome results
None listed