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

Primary Purpose

Pharyngitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ambroxol hydrochloride (Mucoangin?)
benzocaine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA Patients having a sore throat with acute viral pharyngitis. Female and male patients between the ages of 18 and 80 years. The throat pain intensity is rated at least moderate on the VRS (PI). Written Informed Consent is given by the patient. Compliance by the patient seems guaranteed, and 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, and able to return for the study visi ts. EXCLUSION CRITERIA Female patients of child-bearing potential that are: Pregnant Currently breastfeeding NOT practicing acceptable methods of birth control, or NOT planning to contin ue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implan table, injectable contraceptives or double-barrier method. 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 steroids for oral, inhaling or topical application expectorants or antitussives. No physical therapy (e.g. throat compress, throa t rinsing) may be applied during the trial. Patients who have used analgesics or anti-inflammatory agents less than two half-lives of the applicable drug before study entry, or who will require their use in the 3 hours after taking the firs t lozenge. Patients with mouth breathing as a result of nasal congestion. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge. Existing tumour condition currently under treatment. 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

  • Medicover
  • Medicover
  • Medicover
  • Victor Babes Clincial Hospital
  • Regional Student Hospital
  • Regional Clinical Hospital
  • City Clinical Otolaryngological Hospital
  • City Clinical Hospital No. 17
  • City Clinical Hospital No. 11
  • City Clinical Hospital No. 26
  • Academy of Medical Science named after O.S. Kolomyichenko
  • City Clinical Hospital No. 9
  • City Clinical Hospital No. 11
  • Regional Clinical Hospital

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 7, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00148499
Brief Title
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
Official Title
Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-blind,Placebo- and Active-controlled Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (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 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.

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
751 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ambroxol hydrochloride (Mucoangin?)
Intervention Type
Drug
Intervention Name(s)
benzocaine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Patients having a sore throat with acute viral pharyngitis. Female and male patients between the ages of 18 and 80 years. The throat pain intensity is rated at least moderate on the VRS (PI). Written Informed Consent is given by the patient. Compliance by the patient seems guaranteed, and 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, and able to return for the study visi ts. EXCLUSION CRITERIA Female patients of child-bearing potential that are: Pregnant Currently breastfeeding NOT practicing acceptable methods of birth control, or NOT planning to contin ue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implan table, injectable contraceptives or double-barrier method. 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 steroids for oral, inhaling or topical application expectorants or antitussives. No physical therapy (e.g. throat compress, throa t rinsing) may be applied during the trial. Patients who have used analgesics or anti-inflammatory agents less than two half-lives of the applicable drug before study entry, or who will require their use in the 3 hours after taking the firs t lozenge. Patients with mouth breathing as a result of nasal congestion. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge. Existing tumour condition currently under treatment. 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
BI Pharma Ges mbH Wien
Official's Role
Study Chair
Facility Information:
Facility Name
Medicover
City
Bucharest
ZIP/Postal Code
010224
Country
Romania
Facility Name
Medicover
City
Bucharest
ZIP/Postal Code
010626
Country
Romania
Facility Name
Medicover
City
Bucharest
ZIP/Postal Code
021106
Country
Romania
Facility Name
Victor Babes Clincial Hospital
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
Regional Student Hospital
City
Kharkov
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Regional Clinical Hospital
City
Kharkov
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
City Clinical Otolaryngological Hospital
City
Kharkov
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
City Clinical Hospital No. 17
City
Kharkov
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
City Clinical Hospital No. 11
City
Kharkov
ZIP/Postal Code
61050
Country
Ukraine
Facility Name
City Clinical Hospital No. 26
City
Kharkov
ZIP/Postal Code
61072
Country
Ukraine
Facility Name
Academy of Medical Science named after O.S. Kolomyichenko
City
Kiev
ZIP/Postal Code
03057
Country
Ukraine
Facility Name
City Clinical Hospital No. 9
City
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
City Clinical Hospital No. 11
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Regional Clinical Hospital
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.489_U07-1130.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.489_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/19137906
Description
Related Info

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

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