Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 1:33 AM
Study NCT ID:
NCT00883194
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2009-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Effectiveness Pilot Study of PRF-108 and PRF-110 in Healthy Volunteers
Sponsor:
PainReform LTD
Organization:
Study Overview
Official Title:
A Single-center, Randomized, Placebo-controlled, Double-blind, Single-dose, Efficacy of PRF-108 4% and PRF-110 4% Versus Ropivacaine Solution 0.5% in an Experimental Pain Model
Status:
COMPLETED
Status Verified Date:
2020-11
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:
This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.
Detailed Description:
This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.
The purpose of this study is to investigate the safety (side effects if any occurs) associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and Vehicle Gel.
The purpose of this study is to investigate the safety (side effects if any occurs) associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and Vehicle Gel.
Study Oversight
Has Oversight DMC:
False
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?: