Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773846
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2022-11-01
Brief Title:
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
Sponsor:
PainReform LTD
Organization:
PainReform LTD
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Saline Placebo- and Active-Controlled Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy
Status:
COMPLETED
Status Verified Date:
2023-12
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:
PRF-110 is a viscous yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours This is A Phase 3 Randomized Double-Blind Saline Placebo- and Active-Controlled Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy
Detailed Description:
PRF-110 is a unique sustained-release oil-based solution formulation of ropivacaine intended for administration into surgical sites for the prevention of postoperative pain The formulation is designed to have an effect for up to 72 hours It is postulated that PRF-110 will improve postoperative pain management by providing prolonged pain relief at the surgical site thereby reducing the amount of systemic analgesia needed after surgery The slow local release of ropivacaine following administration of PRF-110 has been demonstrated in dissolution studies in postoperative pain studies in animals in an experimental pain study in human volunteers and in an open-label Phase 2 hernia repair trial to result in very low plasma concentrations of drug therefore reducing the probability of systemic adverse events This is a randomized double-blind study to evaluate the efficacy and safety of PRF-110 compared with saline placebo and with ropivacaine hydrochloride injection administered intraoperatively in subjects undergoing unilateral bunionectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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