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Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy

NCT04826328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-08-26

No results posted yet for this study

Summary

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy.

Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy.

Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.

Conditions

  • Pain, Postoperative
  • Bunion

Interventions

DRUG

FX301

FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain

DRUG

Normal Saline

Single peripheral nerve injection

Sponsors & Collaborators

  • Lotus Clinical Research, LLC

    collaborator OTHER

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • William T Andrews, MD, FACP · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-01-11
Completion
2022-03-30
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 NCT04826328 on ClinicalTrials.gov