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

Common Cold Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361399
• Other study ID #: 11640
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2004
• Est. completion date: May 28, 2005

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1088
• Est. completion date: May 28, 2005
• Est. primary completion date: May 28, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Pharyngitis
• Tonsillitis

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
• Acetylsalicylic Acid (Aspirin, BAYE4465)
Single oral application of Aspirin (as lozenge)
• Lidocain
Single oral application of Lidocain (as lozenge)
• Placebo
Single oral application of Placebo (as lozenge)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences SPID		120 minutes
Primary	Pain intensity difference to baseline (PID12 min)		12 minutes
Primary	Pain intensity difference to baseline (PID120 min)		120 minutes
Secondary	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
Secondary	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
Secondary	Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)		60, 120, 180, and 240 minutes post dose
Secondary	Overall assessment of treatment		240 minutes
Secondary	Assessment of safety and tolerability		240 minutes