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Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

NCT05411861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2023-01-11

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 bunionectomy.

Conditions

  • Hallux Valgus and Bunion

Interventions

DRUG

Analgesic Non Narcotic

Injection of protocol-specified volume of local analgesic

Sponsors & Collaborators

  • Cali Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Erol Onel · Cali Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2022-09-26
Completion
2022-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05411861 on ClinicalTrials.gov