Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02174068
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2014-05-26
Brief Title:
A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam
Status:
COMPLETED
Status Verified Date:
2014-07
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:
PARA-NEF
Brief Summary:
Pain remains the leading cause of consultation Despite a wide therapeutic arsenal a significant percentage of patients disclaim little or no pain relief with common analgesics specific or not their type of pain This is especially true in cases of chronic pain and current treatments are associated with many side effects A need for therapeutic innovation is needed Paracetamol is currently the most widely used analgesic worldwide but despite its excellent safety its analgesic effect is limited from moderate to severe pain Many analgesic drug combinations include paracetamol recently the co-administration of paracetamol and nefopam showed a supra-additive antinociceptive effect Van Elstraete AC et al 2013 The development of a formulation associating paracetamol and nefopam first requires searching a possible pharmacokinetic interaction between the two active substances and assessing safety of this combination in healthy volunteers No published studies providing such information
Detailed Description:
This is a randomised cross-over open label trial assessing drug interaction between paracetamol and nefopam in healthy volunteers
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 |
|---|---|---|---|
| 2014-000624-22 | None | None | None |