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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00525044
First received: September 3, 2007
Last updated: April 30, 2014
Last verified: April 2014

September 3, 2007
April 30, 2014
August 2007
January 2008   (final data collection date for primary outcome measure)
Indication of pain on the VRS (verbal rating scale) in the first 3 hours (the patient rates his/her pain on a six point verbal rating scale).
Indication of pain on the VRS(verbal rating scale) in the first 3 hours (the patient rates his/her pain on a six point verbal rating scale).
Complete list of historical versions of study NCT00525044 on ClinicalTrials.gov Archive Site
Patient assesses the effectiveness and the tolerance. Participating doctors assessment of tolerance.
patient assesses the effectiveness and the tolerance Participating doctor?s assessment of tolerance
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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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pharyngitis
  • Drug: Ambroxol
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00525044
18.490
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP