Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis

Phase 3

Completed

• Conditions: Pharyngitis

• Registration Number: NCT00148499
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering from acute viral pharyngitis.

Detailed Description

This is a randomised, double-blind, placebo- and active-controlled parallel group study in adult pat ients, suffering from acute viral pharyngitis and throat pain of at least moderate intensity.

The whole study will last for up to 4 days, on each of test days patients will take one lozenge cont aining Ambroxol hydrochlorid 20 mg/ or placebo/ or benzocaine lozenge 3 mg up to 6 lozenges per day.

Using Patient Diaries the assessment of tolerability and efficacy by the patient will be obtained.

Study Hypothesis:

The primary hypothesis to be tested is the test of superiority of ambroxol 20 mg in comparison to placebo. If and only if the corresponding test of superiority to placebo is statistically significant, the hypothesis of non-inferiority of am broxol 20 mg in comparison to benzocaine 3 mg will be tested.

Comparison(s):

For the primary comparison the placebo lozenges will be used, for the secondary comparison the benzocaine 3 mg lozenges will be used.

Study Timeline

• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Study Start: 2005-10
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: 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 (PID) Time to onset of action after the first lozenge Assessment of efficacy Assessment of tolerability by the patient and investigator Adverse events

Trial Locations

Locations (10)

Medicover; 🇷🇴 Bucharest, Romania

City Clinical Otolaryngological Hospital; 🇺🇦 Kharkov, Ukraine

Victor Babes Clincial Hospital; 🇷🇴 Bucharest, Romania

Regional Student Hospital; 🇺🇦 Kharkov, Ukraine

City Clinical Hospital No. 11; 🇺🇦 Odessa, Ukraine

City Clinical Hospital No. 9; 🇺🇦 Kiev, Ukraine

Regional Clinical Hospital; 🇺🇦 Zaporozhye, Ukraine

City Clinical Hospital No. 26; 🇺🇦 Kharkov, Ukraine

City Clinical Hospital No. 17; 🇺🇦 Kharkov, Ukraine

Academy of Medical Science named after O.S. Kolomyichenko; 🇺🇦 Kiev, Ukraine