Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
NCT ID: NCT00148499
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
751 participants
INTERVENTIONAL
2005-10-31
2006-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ambroxol hydrochloride (Mucoangin?)
benzocaine
Eligibility Criteria
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Inclusion Criteria
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. 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.
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI Pharma Ges mbH Wien
Locations
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Medicover
Bucharest, , Romania
Medicover
Bucharest, , Romania
Medicover
Bucharest, , Romania
Victor Babes Clincial Hospital
Bucharest, , Romania
Regional Student Hospital
Kharkiv, , Ukraine
Regional Clinical Hospital
Kharkiv, , Ukraine
City Clinical Otolaryngological Hospital
Kharkiv, , Ukraine
City Clinical Hospital No. 17
Kharkiv, , Ukraine
City Clinical Hospital No. 11
Kharkiv, , Ukraine
City Clinical Hospital No. 26
Kharkiv, , Ukraine
Academy of Medical Science named after O.S. Kolomyichenko
Kiev, , Ukraine
City Clinical Hospital No. 9
Kiev, , Ukraine
City Clinical Hospital No. 11
Odesa, , Ukraine
Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Countries
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Related Links
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Related Info
Other Identifiers
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18.489
Identifier Type: -
Identifier Source: org_study_id