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

NCT05080959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • Inguinal Herniorrhaphy

Interventions

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

Sponsors & Collaborators

  • Cali Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Erol Onel, MD · Cali Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2021-12-31
Completion
2022-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05080959 on ClinicalTrials.gov