Status:
COMPLETED
Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty
Lead Sponsor:
Innocoll
Conditions:
Pain, Postoperative
Abdominoplasty
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 post...
Detailed Description
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. Patients will u...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Has a body mass index of 18-35 kg/m2.
- Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia.
- Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery.
- Is willing to use opioid analgesia, if needed.
- Exclusion Criteria
- 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, gastrointestinal resection 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 abdominoplasty procedure
Exclusion
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT04785625
Start Date
April 29 2021
End Date
October 27 2021
Last Update
November 21 2022
Active Locations (4)
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1
Lotus Clinical Research
Pasadena, California, United States, 91105
2
Midwest Clinical Research
Dayton, Ohio, United States, 45417
3
HD Research
Bellaire, Texas, United States, 77401
4
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229