Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Pharyngitis

Treatments

Drug: Ambroxol

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00525044

18.490

Details and patient eligibility

About

The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Full description

Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approximately 30-32 patients.

Study Hypothesis:

The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal.

Comparison(s):

PRIMARY ENDPOINT:

Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale).

SECONDARY ENDPOINT (S):

Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale.
Participating doctors assessment of tolerance.

Enrollment

249 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.
Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.
Counting of white blood cell in blood routine examination exceeds 10?109/L.
Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).
Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.
Previous and/or existing tumour condition.
Pregnancy and/or breast-feeding.
Alcohol, and/or drug abuse.
Simultaneous participation in another clinical trial.