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

Completed · Phase 3

Conditions studied: Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy, Colectomy, Reduction Mammoplasty

In brief

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.

Key facts

Study ID

NCT04785638

Run by

Innocoll

People needed

100

Starts

2021-04-14

Expected to finish

2023-01-10

Last updated by the study team

2023-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a body mass index of 18-35 kg/m2.
• Has a planned (nonemergency) open ventral hernia repair, abdominoplasty (with rectus sheath plication, in the opinion of the surgeon), open abdominal hysterectomy, laparoscopic-assisted colectomy, or reduction mammoplasty to be conducted using standard surgical technique under general anesthesia.
• Has the ability and willingness to comply with all study procedures including being domiciled for at least 96 hours after surgery.
• Is willing to use opioid analgesia, if needed.

You may not qualify if…

• Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products.
• Is scheduled for other significant concurrent surgical procedures (eg, cholecystectomy or additional cosmetic procedures concurrent with abdominoplasty).
• Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication.
• Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the study surgery.
• For open hernia repair, has open ventral hernia with primary suture repair and mesh placement requiring an incisional length greater than 12 cm.

Where it is running

• North Alabama Medical Center — Florence, Alabama, United States
• Helen Keller Hospital — Sheffield, Alabama, United States
• Lotus Clinical Research — Pasadena, California, United States
• Midwest Clinical Research — Dayton, Ohio, United States
• Daneshvari Solanki — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Memorial Hermann — Houston, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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