Clinical trial NCT01361399: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Pharyngitis
Tonsillitis
Keywords: Sore Throat
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 1088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Sum of pain intensity differences SPID
timeFrame: 120 minutes
measure: Pain intensity difference to baseline (PID12 min)
timeFrame: 12 minutes
measure: Pain intensity difference to baseline (PID120 min)
timeFrame: 120 minutes
Secondary outcomes:
measure: Pain intensity difference to baseline (PID)
timeFrame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
measure: Total pain relief to baseline (TOTPAR)
timeFrame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
measure: Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
timeFrame: 60, 120, 180, and 240 minutes post dose
measure: Overall assessment of treatment
timeFrame: 240 minutes
measure: Assessment of safety and tolerability
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Mocow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Lugansk
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
affiliation: Bayer
name: Bayer Study Director
References: