Clinical trial NCT00525044: Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 249
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline
timeFrame: pre-dose baseline and 30, 60, 120, and 180 minutes
Secondary outcomes:
measure: Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge
timeFrame: 0.5, 1, 2 and 3 hours
measure: Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge
timeFrame: pre-dose baseline and 0.5, 1, 2 and 3 hours
measure: Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation
timeFrame: Day 1 and Day 2
measure: Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: ENT Subsidiary of Fudan University Hospital
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim Shanghai
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: