NCT05080959

A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Cali Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Herniorrhaphy

Interventions

Type	Name	Description
DRUG	CPL-01	Subjects will receive a single dose
DRUG	Naropin 150 MG Per 20 ML Injection	Subjects will receive a single dose
DRUG	Placebo	Subjects will receive a single dose

Timeline

• Start date: 2021-07-28
• Primary completion: 2021-12-31
• Completion: 2022-06-10
• First posted: 2021-10-18
• Last updated: 2022-07-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study