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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01361399
First received: May 25, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Common Cold
Pharyngitis
Tonsillitis
Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Drug: Lidocain
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sum of pain intensity differences SPID [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
  • Pain intensity difference to baseline (PID12 min) [ Time Frame: 12 minutes ] [ Designated as safety issue: No ]
  • Pain intensity difference to baseline (PID120 min) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity difference to baseline (PID) [ Time Frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose ] [ Designated as safety issue: No ]
  • Total pain relief to baseline (TOTPAR) [ Time Frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose ] [ Designated as safety issue: No ]
  • Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain) [ Time Frame: 60, 120, 180, and 240 minutes post dose ] [ Designated as safety issue: No ]
  • Overall assessment of treatment [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 1088
Study Start Date: November 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
Active Comparator: Arm 2 Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Single oral application of Aspirin (as lozenge)
Active Comparator: Arm 3 Drug: Lidocain
Single oral application of Lidocain (as lozenge)
Placebo Comparator: Arm 4 Drug: Placebo
Single oral application of Placebo (as lozenge)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361399

Locations
Russian Federation
ask Contact, Russian Federation
Ukraine
ask Contact, Ukraine
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT01361399     History of Changes
Other Study ID Numbers: 11640
Study First Received: May 25, 2011
Last Updated: May 25, 2011
Health Authority: Russia: Federal Agency of Drugs Quality Control
Ukraine: Ministry of Health

Keywords provided by Bayer:
Sore Throat

Additional relevant MeSH terms:
Common Cold
Pharyngitis
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Virus Diseases
Aspirin
Lidocaine
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents

ClinicalTrials.gov processed this record on November 25, 2014