Status:
COMPLETED
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
Lead Sponsor:
Innocoll
Conditions:
Pain, Postoperative
Hernia, Ventral
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04785638
Start Date
April 14 2021
End Date
January 10 2023
Last Update
February 13 2023
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
North Alabama Medical Center
Florence, Alabama, United States, 35630
2
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
3
Lotus Clinical Research
Pasadena, California, United States, 91105
4
Midwest Clinical Research
Dayton, Ohio, United States, 45417