Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01307020
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2011-02-28
Brief Title:
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Sponsor:
Menarini Group
Organization:
Menarini Group
Study Overview
Official Title:
Double-blind Randomised Placebo and Active Controlled Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKPTRIS With TRAMHCL in Comparison With the Single Agents on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
Status:
COMPLETED
Status Verified Date:
2013-07
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:
DEX-TRA 02
Brief Summary:
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction Ibuprofen will be used as an active control to validate the pain model
Detailed Description:
The aim of this study is to develop a combination of Dexketoprofen Trometamol DKPTRIS and Tramadol Hydrochloride TRAMHCl for the treatment of acute moderate to severe pain based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain particularly of moderate to severe intensity
DKPTRIS and TRAMHCl have different mechanisms of action therefore their combination is expect to result in an additive or synergistic analgesia thus allowing a decrease in the required doses of the individual agents and consequently a reduced risk of adverse events In this study patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKPTRIS TRAMHCl the four corresponding single treatments placebo and ibuprofen Treatment administration will be followed by a 24-hour pain and analgesic effect assessment
DKPTRIS and TRAMHCl have different mechanisms of action therefore their combination is expect to result in an additive or synergistic analgesia thus allowing a decrease in the required doses of the individual agents and consequently a reduced risk of adverse events In this study patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKPTRIS TRAMHCl the four corresponding single treatments placebo and ibuprofen Treatment administration will be followed by a 24-hour pain and analgesic effect assessment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-022798-32 | EUDRACT_NUMBER | None | None |