Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148499
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-07
Brief Title:
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat With AcuteViralpharyngitis
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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-blindPlacebo- and Active-controlled Parallel Group Study
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Comparisons
For the primary comparison the placebo lozenges will be used for the secondary comparison the benzocaine 3 mg lozenges will be used
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
Comparisons
For the primary comparison the placebo lozenges will be used for the secondary comparison the benzocaine 3 mg lozenges will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None