Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-29 @ 7:27 PM
Study NCT ID:
NCT05080959
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
Sponsor:
Cali Pharmaceuticals LLC
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in Postoperative Pain After Open Inguinal Herniorrhaphy
Status:
COMPLETED
Status Verified Date:
2021-10
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 Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
Detailed Description:
A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy.
Study Oversight
Has Oversight DMC:
True
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?: