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

Status and phase: Completed; Phase 3

Conditions: Tonsillitis; Pharyngitis; Common Cold

Treatments: Drug: Lidocain; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01361399

11640

Details and patient eligibility

About

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.

Enrollment: 1,088 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,088 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

Arm 2

Active Comparator group

Treatment:

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

Active Comparator group

Treatment:

Drug: Lidocain

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo