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

October 28, 2013 updated by: Boehringer Ingelheim

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Boksburg, South Africa, 1461
        • Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa, 7646
        • Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa, 7700
        • Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa, 7945
        • Boehringer Ingelheim Investigational Site
      • Durban, South Africa, 4091
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa, 2033
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa, 2192
        • Boehringer Ingelheim Investigational Site
      • Krugersdorp, South Africa, 1739
        • Boehringer Ingelheim Investigational Site
      • Midrand, South Africa, 1685
        • Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa, 0038
        • Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa, 0157
        • Boehringer Ingelheim Investigational Site
      • Sandton, South Africa, 2021
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  1. Patients having a sore throat with acute viral pharyngitis.
  2. Female and male patients from 12 and less than 18 years of age.
  3. The throat pain intensity is rated at least "moderate" on the VRS(PI).
  4. Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent.
  5. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.
  6. Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, or known reliable patient, and able t o return for the study visits.

EXCLUSION CRITERIA

  1. Female patients who have begun menstruating and are:

    1. Pregnant
    2. Currently breastfeeding
    3. Of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implantable or injectable contraceptives. Abstinenc e can be used as contraception, at the discretion of the investigator.
  2. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).
  3. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.
  4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
  5. Patient who in the past week, or during the study will require treatment with the following: antibiotics analgesics anti-inflammatory agents steroids fo r oral, inhaling or topical application expectorants or antitussives. No phys ical therapy (e.g. throat compress) may be applied during the trial.
  6. Patients with mouth breathing as a result of nasal congestion.
  7. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.
  8. Previous and/or existing tumour condition.
  9. Alcohol, and/or drug abuse.
  10. Any clinical condition which, in the opinion of the investigator would not a llow safe completion of the protocol and safe administration of trial medication.
  11. Any investigational therapy within 30 days prior to randomisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

November 1, 2005

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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