Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485667
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2007-06-11
Brief Title:
Phase 1 Thorough QT Study in Young Healthy Volunteers
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
Pacira Pharmaceuticals Inc
Study Overview
Official Title:
Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QTQTc Interval in Young Healthy Volunteers A Prospective Randomized Placebo- and Positive-controlled Double Blind Single-centre Crossover Phase 1 Study
Status:
COMPLETED
Status Verified Date:
2021-02
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:
TQT
Brief Summary:
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction
Detailed Description:
Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402 A formulation of bupivacaine given as a single injection after surgery that could provide adequate continuous and extended pain relief would greatly simplify postoperative pain management reduce the need for repeated administration and minimize break-through episodes of pain
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 |
|---|---|---|---|
| EudraCT Number 2007-001981-33 | None | None | None |
| Richmond No C07027 | None | None | None |