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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00148499 |
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.
Condition | Intervention | Phase |
---|---|---|
Pharyngitis |
Drug: Ambroxol hydrochloride (Mucoangin?) Drug: benzocaine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-Blind,Placebo- and Active-Controlled Parallel Group Study |
Estimated Enrollment: | 750 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Female patients of child-bearing potential that are:
Romania | |
Medicover | |
Bucharest, Romania, 010626 | |
Medicover | |
Bucharest, Romania, 021106 | |
Medicover | |
Bucharest, Romania, 010224 | |
Victor Babes Clincial Hospital | |
Bucharest, Romania, 030303 | |
Ukraine | |
City Clinical Otolaryngological Hospital | |
Kharkov, Ukraine, 61024 | |
City Clinical Hospital No. 11 | |
Kharkov, Ukraine, 61050 | |
Regional Student Hospital | |
Kharkov, Ukraine, 61002 | |
City Clinical Hospital No. 17 | |
Kharkov, Ukraine, 61037 | |
Regional Clinical Hospital | |
Kharkov, Ukraine, 61022 | |
City Clinical Hospital No. 9 | |
Kiev, Ukraine, 04112 | |
Academy of Medical Science named after O.S. Kolomyichenko | |
Kiev, Ukraine, 03057 | |
City Clinical Hospital No. 11 | |
Odessa, Ukraine, 65006 | |
Regional Clinical Hospital | |
Zaporozhye, Ukraine, 69600 | |
City Clinical Hospital No. 26 | |
Kharkov, Ukraine, 61072 |
Study Chair: | Boehringer Ingelheim Study Coordinator | BI Pharma Ges mbH Wien |
Study ID Numbers: | 18.489 |
Study First Received: | September 7, 2005 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00148499 |
Health Authority: | Austria: Pharmacology Centre , Ministry of Health; Austria: National Drug Agency |
Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Benzocaine Pain |
Stomatognathic Diseases Pharyngitis Ambroxol Pharyngeal Diseases |
Respiratory System Agents Sensory System Agents Therapeutic Uses Expectorants Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Anesthetics, Local Pharmacologic Actions |