The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose bas eline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The pain intensity will be assessed by the patient on a 6-point rating scale before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter. The patient enters the rating in the patient's diary. Study Hypothesis: It will be tested whether a statistically significant difference exists in the S PIDnorm after the intake of the 1st lozenge between the group treated with ambro xol lozenges and the group treated with placebo lozenges. Comparison(s): Placebo comparison
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Boehringer Ingelheim Investigational Site
Boksburg, South Africa
Boehringer Ingelheim Investigational Site
Cape Town, South Africa
Boehringer Ingelheim Investigational Site
Cape Town, South Africa
The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose baseline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline (SPIDnorm).
Pain intensity (PI) and pain intensity difference from pre-dose baseline Time to onset of action of lozenge Assessment of redness of pharyngeal mucosa at pre-dose baseline and end of study Efficacy and tolerability assessment Adverse events
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Boehringer Ingelheim Investigational Site
Cape Town, South Africa
Boehringer Ingelheim Investigational Site
Durban, South Africa
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
Boehringer Ingelheim Investigational Site
Midrand, South Africa
Boehringer Ingelheim Investigational Site
Pretoria, South Africa
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