Pharyngitis Clinical Trial
Official title:
Efficacy and Tolerability of Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis - A Randomised, Double-blind, Placebo-controlled Parallel Group Study. AMBROSIA: Ambroxol Lozenges In Sore Throat In Adolescents
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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