Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis

Phase 3

Completed

• Conditions: Pharyngitis

• Registration Number: NCT00144274
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇿🇦 Sandton, South Africa