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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ambroxol

Criteria

1. 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.

1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).

2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.

3. Counting of white blood cell in blood routine examination exceeds 10?109/L.

4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.

5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).

6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.

7. Previous and/or existing tumour condition.

8. Pregnancy and/or breast-feeding.

9. Alcohol, and/or drug abuse.

10. Simultaneous participation in another clinical trial.