Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02777970
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2016-05-13
Brief Title:
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Sponsor:
Menarini Group
Organization:
Menarini Group
Study Overview
Official Title:
Analgesic Efficacy of Oral Dexketoprofen TrometamolTramadol Hydrochloride Versus Tramadol HydrochlorideParacetamol a Randomised Double-blind Placebo and Active-controlled Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study
Status:
COMPLETED
Status Verified Date:
2021-03
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:
DAVID
Brief Summary:
The study is aimed to evaluate the analgesic efficacy of TRAMHClDKPTRIS 75mg25mg oral fixed drug combination in comparison with TRAMHCl paracetamol 75mg650mg in the treatment of moderate to severe acute pain
Detailed Description:
The present phase IV study is a randomised double-blind placebo and active-controlled parallel group study in moderate to severe acute pain after removal of impacted lower third molar
In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 221 ratio
TRAMHCLDKPTRIS
ParacetamolTRAMHCL
Placebo
In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 221 ratio
TRAMHCLDKPTRIS
ParacetamolTRAMHCL
Placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None