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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00148499
First received: September 7, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pharyngitis
Drug: Ambroxol hydrochloride (Mucoangin?)
Drug: benzocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Estimated Enrollment: 751
Study Start Date: October 2005
Estimated Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Patients having a sore throat with acute viral pharyngitis.
  2. Female and male patients between the ages of 18 and 80 years.
  3. The throat pain intensity is rated at least moderate on the VRS (PI).
  4. Written Informed Consent is given by the patient.
  5. Compliance by the patient seems guaranteed, and 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, and able to return for the study visi ts.

EXCLUSION CRITERIA

  1. Female patients of child-bearing potential that are:

    1. Pregnant
    2. Currently breastfeeding
    3. 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.
  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 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.
  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. Existing tumour condition currently under treatment.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148499

Locations
Romania
Victor Babes Clincial Hospital
Bucharest, Romania, 030303
Medicover
Bucharest, Romania, 021106
Medicover
Bucharest, Romania, 010224
Medicover
Bucharest, Romania, 010626
Ukraine
City Clinical Hospital No. 26
Kharkov, Ukraine, 61072
Regional Clinical Hospital
Kharkov, Ukraine, 61022
City Clinical Hospital No. 11
Kharkov, Ukraine, 61050
Regional Student Hospital
Kharkov, Ukraine, 61002
City Clinical Hospital No. 17
Kharkov, Ukraine, 61037
City Clinical Otolaryngological Hospital
Kharkov, Ukraine, 61024
Academy of Medical Science named after O.S. Kolomyichenko
Kiev, Ukraine, 03057
City Clinical Hospital No. 9
Kiev, Ukraine, 04112
City Clinical Hospital No. 11
Odessa, Ukraine, 65006
Regional Clinical Hospital
Zaporozhye, Ukraine, 69600
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Pharma Ges mbH Wien
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00148499     History of Changes
Other Study ID Numbers: 18.489
Study First Received: September 7, 2005
Last Updated: October 30, 2013
Health Authority: Austria: Pharmacology Centre , Ministry of Health
Austria: National Drug Agency

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ambroxol
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014