← Back to Search

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

Phase 3
Waitlist Available
Research Sponsored by Innocoll
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests a bupivacaine implant to manage pain in patients after soft-tissue surgeries. The implant releases medication at the surgery site to numb the area and reduce pain. It aims to help patients who undergo surgeries like hernia repair and tummy tucks. Liposomal bupivacaine has been shown to be effective in managing postoperative pain in various surgeries, including abdominal and plastic surgeries.

Eligible Conditions
  • Infections
  • Ventral Hernia
  • Postoperative Pain
  • Tummy Tuck
  • Hysterectomy
  • Colectomy
  • Breast Reduction Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the safety and tolerability
Secondary study objectives
AUC
AUC0-∞
Cmax
+4 more
Other study objectives
15-item Quality of Recovery (QoR-15) Questionnaire
Opioid-related Symptom Distress Scale (OR-SDS)
Patient Global Assessment (PGA) as Related to Postoperative Pain
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: INL-001 (bupivacaine hydrochloride) implantExperimental Treatment1 Intervention
INL-001 (bupivacaine hydrochloride) implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INL-001 (bupivacaine hydrochloride) implant
2021
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

InnocollLead Sponsor
20 Previous Clinical Trials
4,890 Total Patients Enrolled
2 Trials studying Infections
2,104 Patients Enrolled for Infections
Anne ArriagaStudy DirectorLotus Clinical Research
1 Previous Clinical Trials
366 Total Patients Enrolled
~21 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top