MedTrace Logo

Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

NCT04785625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-11-21

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.

Conditions

  • Pain, Postoperative
  • Abdominoplasty

Interventions

COMBINATION_PRODUCT

Bupivacaine Hydrochloride

INL-001 (bupivacaine hydrochloride) implant

COMBINATION_PRODUCT

Placebo collagen-matrix implant

Placebo collagen-matrix implant

Sponsors & Collaborators

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Anne Arriaga · Lotus Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2021-10-27
Completion
2021-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04785625 on ClinicalTrials.gov