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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148499
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

September 7, 2005
September 8, 2005
December 28, 2017
October 2005
June 2006   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT00148499 on Archive Site
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
Same as current
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Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
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
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.

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.


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

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: Ambroxol hydrochloride (Mucoangin?)
  • Drug: benzocaine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2006
June 2006   (Final data collection date for primary outcome measure)


  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.


  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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Romania,   Ukraine
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Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator BI Pharma Ges mbH Wien
Boehringer Ingelheim
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP