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

Primary Purpose

Pharyngitis

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Ambroxol Lozenge
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA Patients having a sore throat with acute viral pharyngitis. Female and male patients from 12 and less than 18 years of age. The throat pain intensity is rated at least "moderate" on the VRS(PI). Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary. 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 Female patients who have begun menstruating and are: Pregnant Currently breastfeeding 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. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate). First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 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. Patients with mouth breathing as a result of nasal congestion. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge. Previous and/or existing tumour condition. Alcohol, and/or drug abuse. 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. Any investigational therapy within 30 days prior to randomisation.

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 2, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144274
Brief Title
Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ambroxol Lozenge
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Patients having a sore throat with acute viral pharyngitis. Female and male patients from 12 and less than 18 years of age. The throat pain intensity is rated at least "moderate" on the VRS(PI). Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary. 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 Female patients who have begun menstruating and are: Pregnant Currently breastfeeding 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. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate). First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 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. Patients with mouth breathing as a result of nasal congestion. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge. Previous and/or existing tumour condition. Alcohol, and/or drug abuse. 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. Any investigational therapy within 30 days prior to randomisation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. South Africa (Pty.) Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Boksburg
ZIP/Postal Code
1461
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Cape Town
ZIP/Postal Code
7945
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Johannesburg
ZIP/Postal Code
2033
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Johannesburg
ZIP/Postal Code
2192
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Krugersdorp
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Midrand
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Pretoria
ZIP/Postal Code
0038
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Sandton
ZIP/Postal Code
2021
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.487_U06-1404.pdf
Description
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Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis

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