The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg ambroxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suffering from acute viral pharyngitis.

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).

Condition	Intervention	Phase
Pharyngitis	Drug: Ambroxol Lozenge	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  220

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg ambroxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suffering 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 SPIDnorm after the intake of the 1st lozenge between the group treated with ambroxol lozenges and the group treated with placebo lozenges.

Comparison(s):

Placebo comparison

Ages Eligible for Study:  12 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA

1. Patients having a sore throat with acute viral pharyngitis.
2. Female and male patients from 12 and less than 18 years of age.
3. The throat pain intensity is rated at least "moderate" on the VRS(PI).
4. Written Informed Consent is given by the patient''''s parent/legal guardian, and the patient is able to give Assent.
5. Compliance by the patient seems guaranteed, and the 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, or known reliable patient, and able to return for the study visits.

EXCLUSION CRITERIA

1. Female patients who have begun menstruating and are:

   1. Pregnant
   2. Currently breastfeeding
   3. 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. Abstinence can be used as contraception, at the discretion of the investigator.
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; analgesics; anti-inflammatory agents; steroids for oral, inhaling or topical application; expectorants or antitussives. No physical therapy (e.g. throat compress) may be applied during the trial.
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. Previous and/or existing tumour condition.
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  NCT00144274

Michelle Port, Dr      +27 (11) 348-2521  Ext. 2521    port@jnb.boehringer-ingelheim.com

South Africa
      Health Emporium, Midrand,  1685,  South Africa; Recruiting
      122 Duxbury Road, Pretoria,  0038,  South Africa; Recruiting
      174 Craddock Avenue, Pretoria,  0157,  South Africa; Recruiting
      80 Gemsbok Avenue, Johannesburg,  2033,  South Africa; Recruiting
      127 Louis Botha Avenue, Johannesburg,  2192,  South Africa; Recruiting
      72 Shannon Road, Krugersdorp,  1739,  South Africa; Recruiting
      21 Concert Boulevard, Cape Town,  7945,  South Africa; Recruiting
      Sandton Medi-Clinic, SANDTON,  2021,  South Africa; Recruiting
      14 Malherbe Street, Cape Town,  7646,  South Africa; Recruiting
      1 Paul Smit Street, Boksburg,  1461,  South Africa; Recruiting
      Kenilworth Mediclinic, Cape Town,  7700,  South Africa; Recruiting

Study chairs or principal investigators

Michelle Port, Dr,  Study Chair,  B.I. South Africa (Pty.) Ltd.   

Study ID Numbers:  18.487
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144274
Health Authority: South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2005-09-06