Sore Throat Clinical Trial
Official title:
A Multi-center, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat Caused by URTI in Adults.
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).
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