The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg ambroxol 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 III

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  750

This is a randomised, double-blind, placebo- and active-controlled parallel group study in adult patients, 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 containing 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 ambroxol 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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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 following the first intake of study medication, and able to return for the study visits.

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 continue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implantable, injectable contraceptives or double-barrier method.
2. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
3. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurred 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, throat 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 first lozenge.
6. Patients with mouth breathing as a result of nasal congestion.
7. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the 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 allow safe completion of the protocol and safe administration of trial medication.
11. Any investigational therapy within 30 days prior to randomisation.

Please refer to this study by ClinicalTrials.gov identifier  NCT00148499

Elena Uvarova, Dr      +43 (1) 80105-7717  Ext. 7717    elena.uvarova@vie.boehringer-ingelheim.com

Romania
      CMDTA "Dr. N. Kretzulescu", Bucharest,  050042,  Romania
      Unirea Medical Center, Bucharest,  030827,  Romania
      Medsana Medical Center Bucharest, Bucharest,  050521,  Romania
      Medicover, Bucharest,  010626,  Romania
      Medicover, Bucharest,  021106,  Romania
      Medicover, Bucharest,  010224,  Romania
Ukraine
      Regional Student Hospital, Kharkov,  61002,  Ukraine
      City Clinical Hospital No. 26, Kharkov,  61072,  Ukraine
      Regional Clinical Hospital, Kharkov,  61022,  Ukraine
      Central City Clinical Hospital, Kiev,  01601,  Ukraine
      City Clinical Hospital No. 9, Kiev,  04112,  Ukraine
      Academy of Medical Science named after O.S. Kolomyichenko, Kiev,  03057,  Ukraine
      City Clinical Hospital No. 11, Odessa,  65006,  Ukraine
      Regional Clinical Hospital, Zaporozhye,  69600,  Ukraine
      City Clinical Otolaryngological Hospital, Kharkov,  61024,  Ukraine
      City Clinical Hospital No. 11, Kharkov,  61050,  Ukraine

Study chairs or principal investigators

Elena Uvarova, Dr,  Study Chair,  BI Pharma Ges mbH Wien   

Study ID Numbers:  18.489
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148499
Health Authority: Romania: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13