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An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

NCT04785638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-13

No results posted yet for this study

Summary

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

Conditions

  • Pain, Postoperative
  • Hernia, Ventral
  • Abdominoplasty
  • Hysterectomy
  • Colectomy
  • Reduction Mammoplasty

Interventions

COMBINATION_PRODUCT

INL-001 (bupivacaine hydrochloride) implant

INL-001 (bupivacaine hydrochloride) implant

Sponsors & Collaborators

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Anne Arriaga · Lotus Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2023-01-10
Completion
2023-01-10
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 NCT04785638 on ClinicalTrials.gov