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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00525044
First received: September 3, 2007
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pharyngitis
 Drug: Ambroxol
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • Patient assesses the effectiveness and the tolerance. Participating doctors assessment of tolerance.

Estimated Enrollment: 250
Estimated Study Completion Date: January 2008
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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525044

Locations
China
Boehringer Ingelheim Investigational Site
Nanjing, China
ENT Subsidiary of Fudan University Hospital
Shanghai, China
Boehringer Ingelheim Investigational Site
Shanghai, China
Boehringer Ingelheim Investigational Site
Wuhan, China
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00525044     History of Changes
Other Study ID Numbers: 18.490
Study First Received: September 3, 2007
Last Updated: May 11, 2012
Health Authority: China: SFDA

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Ambroxol
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013