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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00148499
Other study ID # 18.489
Secondary ID
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated December 27, 2017
Start date October 2005
Est. completion date June 2006

Study information

Verified date December 2017
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering from acute viral pharyngitis.


Description:

This is a randomised, double-blind, placebo- and active-controlled parallel group study in adult pat ients, suffering from acute viral pharyngitis and throat pain of at least moderate intensity.

The whole study will last for up to 4 days, on each of test days patients will take one lozenge cont aining Ambroxol hydrochlorid 20 mg/ or placebo/ or benzocaine lozenge 3 mg up to 6 lozenges per day.

Using Patient Diaries the assessment of tolerability and efficacy by the patient will be obtained.

Study Hypothesis:

The primary hypothesis to be tested is the test of superiority of ambroxol 20 mg in comparison to placebo. If and only if the corresponding test of superiority to placebo is statistically significant, the hypothesis of non-inferiority of am broxol 20 mg in comparison to benzocaine 3 mg will be tested.

Comparison(s):

For the primary comparison the placebo lozenges will be used, for the secondary comparison the benzocaine 3 mg lozenges will be used.


Recruitment information / eligibility

Status Completed
Enrollment 751
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility INCLUSION CRITERIA

1. Patients having a sore throat with acute viral pharyngitis.

2. Female and male patients between the ages of 18 and 80 years.

3. The throat pain intensity is rated at least moderate on the VRS (PI).

4. Written Informed Consent is given by the patient.

5. Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the patient diary.

6. Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, and able to return for the study visi ts.

EXCLUSION CRITERIA

1. Female patients of child-bearing potential that are:

1. Pregnant

2. Currently breastfeeding

3. NOT practicing acceptable methods of birth control, or NOT planning to contin ue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implan table, injectable contraceptives or double-barrier method.

2. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).

3. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.

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

5. Patient who in the past week, or during the study will require treatment with the following: antibiotics steroids for oral, inhaling or topical application expectorants or antitussives. No physical therapy (e.g. throat compress, throa t rinsing) may be applied during the trial. Patients who have used analgesics or anti-inflammatory agents less than two half-lives of the applicable drug before study entry, or who will require their use in the 3 hours after taking the firs t lozenge.

6. Patients with mouth breathing as a result of nasal congestion.

7. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.

8. Existing tumour condition currently under treatment.

9. Alcohol, and/or drug abuse.

10. Any clinical condition which, in the opinion of the investigator would not a llow safe completion of the protocol and safe administration of trial medication.

11. Any investigational therapy within 30 days prior to randomisation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ambroxol hydrochloride (Mucoangin?)

benzocaine


Locations

Country Name City State
Romania Medicover Bucharest
Romania Medicover Bucharest
Romania Medicover Bucharest
Romania Victor Babes Clincial Hospital Bucharest
Ukraine City Clinical Hospital No. 11 Kharkov
Ukraine City Clinical Hospital No. 17 Kharkov
Ukraine City Clinical Hospital No. 26 Kharkov
Ukraine City Clinical Otolaryngological Hospital Kharkov
Ukraine Regional Clinical Hospital Kharkov
Ukraine Regional Student Hospital Kharkov
Ukraine Academy of Medical Science named after O.S. Kolomyichenko Kiev
Ukraine City Clinical Hospital No. 9 Kiev
Ukraine City Clinical Hospital No. 11 Odessa
Ukraine Regional Clinical Hospital Zaporozhye

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Romania,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Endpoint: Time-weighted average of the pain intensity difference from pre-dose baseline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline (SPIDnorm)
Secondary Pain intensity (PI) and pain intensity difference from pre-dose baseline (PID) Time to onset of action after the first lozenge Assessment of efficacy Assessment of tolerability by the patient and investigator Adverse events
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