NCT00525044

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

Double-blind, Randomized, Placebo-controlled Trial to Investigate the Efficacy and Tolerance of Ambroxol Lozenges 20 mg in the Treatment of Sore Throat in Patients With Acute Viral Pharyngitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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): 1. 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. 2. Participating doctors assessment of tolerance.

Conditions

• Pharyngitis

Interventions

Type	Name	Description
DRUG	Ambroxol
DRUG	Placebo

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-09-05
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

4 sites across 1 country: China