A multi-center, double-blind, randomized, parallel-group, placebo-controlled study to determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore throat caused by acute upper respiratory tract infection in adults.
This multi-center, double-blind, randomized, parallel-group, placebo-controlled study consists of two parts, an initial efficacy and safety part performed at the clinic on the first treatment day and a safety follow up home-use treatment part with an intermediate site visit. Following screening and randomization, subjects suffering from throat pain caused by an acute upper respiratory tract infection will receive a single dose of study medication, benzocaine 8 mg or placebo lozenge, and will be followed for a 3 hour assessment period where primary and secondary efficacy measurements will be collected. Onset and duration of what the subject consider to be perceptible and meaningful pain relief, respectively, will be measured by collecting time point for reported onset in relation to time of intake of the single dose. The subjects will assess their pain intensity and the degree of difficulty swallowing during multiple assessment time points throughout the 3 hour period on 11-point numerical rating scales (NRS) where 0=no pain/not difficult, 10=very severe pain/very difficult. The subjects will rate their sore throat condition in a subject questionnaire at baseline and after 2 and approximately 72 hours of treatment. The subjects will also rate how satisfied they were with the assigned study medication as a treatment for sore throat in a global evaluation assessment at the end of the 3 hour assessment period and after approximately 72 hours of treatment. After initiation of treatment and the initial efficacy part of the study (Day 1), the subjects will be released for home based treatment according to label to complete the safety part of the study. The subjects will be equipped with study medication according to randomization and diaries to record number of study medication doses taken per day. The subjects will be instructed to follow their respective treatment label and return to the site for safety follow up at study Day 4 (target approximately 72 hours of treatment) and at the end of treatment, at Day 6 (target approximately 120 hours of treatment).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Railway Clinical Hospital n.a. N.A. Semashko Lyublino railway station of the Russian Railways, Stavropolskaya str., 23, build.1,
Moscow, Russia
Time to meaningful pain relief.
A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced meaningful pain relief.
Time frame: 3 hours
Time to perceptible pain relief (onset of therapeutic effect).
A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced perceptible pain relief.
Time frame: 3 hours
Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Time frame: 15 minutes
Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Time frame: 3 hours
Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Time frame: 15 minutes
Mean change from baseline in self-ratings of difficulty swallowing based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
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City Clinical Hospital n.a. V.M. Buyanov Bakinskaya str., 26
Moscow, Russia
Central Clinical Hospital of Russian Academy of Sciences Litovskiy bulvar, 1A
Moscow, Russia
Federal State Budgetary Institution "Policlinic #5" of Administrative Department of the President of the Russian Federation Plyushchikha str., 14
Moscow, Russia
Unimed-C 26 Bakinskikh Komissarov str., 11
Moscow, Russia
Clinic of the Modern Medicine Pobedy ploshad, 2, bldg. 1
Moscow, Russia
State Budgetary Healthcare Institution City Clinical Hospital n.a. M.E. Zhadkevich
Moscow, Russia
Hospital of Russian Academy of Sience Oktyabrskiy prospect, 3
Moscow, Russia
International Medical Centre SOGAZ Malaya Konushennaya str., 8A
Saint Petersburg, Russia
" City Polyclinic #25 of the Nevsky District of SPB" Prospekt Solidarnosti, 1, bldg 1, litera "А"
Saint Petersburg, Russia
...and 9 more locations
Mean change from baseline in self-ratings of difficulty swallowing based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Time frame: 3 hours
Continuous period of time within the 3 hour test period with perceptible pain relief.
Continuous period of time within the 3 hour test period with perceptible pain relief.
Time frame: 3 hours
Continuous period of time within the 3 hour test period with meaningful pain relief.
Continuous period of time within the 3 hour test period with meaningful pain relief.
Time frame: 3 hours
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition diverts the subject's concentration, assessed after 2 and 72 hour of treatment, respectively.
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition diverts the subject's concentration, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition makes it difficult for the subject to speak, assessed after 2 and 72 hour of treatment, respectively.
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition makes it difficult for the subject to speak, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the degree of experienced improvement in their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Subject ratings with respect to the degree of experienced improvement in their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the extent to which they were able to forget their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Subject ratings with respect to the extent to which they were able to forget their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the degree of overall satisfaction with their assigned study medication for sore throat, rated at the end of the 3 hour assessment period and 72 hours of treatment, respectively.
Subject ratings with respect to the degree of overall satisfaction with their assigned study medication for sore throat, rated at the end of the 3 hour assessment period and 72 hours of treatment, respectively.
Time frame: 72 hours
Frequency and severity of treatment emergent AEs reported during the study
Frequency and severity of treatment emergent AEs reported during the study
Time frame: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment
Time frame: Through study completion, an average of 5 months
Occurrence of serious AEs (SAEs), and AEs resulting in pre-mature withdrawal from the study
Occurrence of serious AEs (SAEs), and AEs resulting in pre-mature withdrawal from the study
Time frame: Through study completion, an average of 5 months.