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

NCT04785625 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: INN-CB-024
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 4

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 postoperative analgesia.

Conditions

Pain, Postoperative; Abdominoplasty

Keywords

Pain; Analgesia; Postoperative; Abdominoplasty; Bupivacaine; Implant; Postsurgical; Safety; Opioid; Tummy tuck; Efficacy; Post-operative; Post-surgical; Surgery; Placebo; Randomized; Double-blind; Phase 3; Nonopioid; Local anesthetic

Outcome Measures

Primary Outcomes (1)

• SPI24

  Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 24hours (ie, the area under the NRS PI curve from 0 to 24 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑\[PI x (time t - time t-1)\], where "t" represents a given time point,"t-1" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.

  0 to 24 hours

Secondary Outcomes (1)

• The secondary objective is to assess the safety and tolerability of INL 001 implants after placement

  Day 1 through Day 30

Other Outcomes (5)

• SPI48

  0 to 48 hours

• SPI72

  0 to 72 hours

• Proportion of patients who are opioid free through 24 hours

  Time 0 through 24 hours

Study Arms (2)

INL-001 (bupivacaine hydrochloride) implant

EXPERIMENTAL

INL-001 (bupivacaine hydrochloride) implant

Combination Product: Bupivacaine Hydrochloride

Placebo implant

PLACEBO COMPARATOR

Placebo collagen-matrix implant

Combination Product: Placebo collagen-matrix implant

Interventions

Bupivacaine Hydrochloride COMBINATION_PRODUCT

INL-001 (bupivacaine hydrochloride) implant

Also known as: XARACOLL (bupivacaine hydrochloride) Implant

INL-001 (bupivacaine hydrochloride) implant

Placebo collagen-matrix implant COMBINATION_PRODUCT

Placebo collagen-matrix implant

Placebo implant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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, 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

Sponsors & Collaborators

• Innocoll: lead

Study Sites (4)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

HD Research

Bellaire, Texas, 77401, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Beaton AC, Solanki D, Salazar H, Folkerth S, Singla N, Minkowitz HS, Leiman D, Vaughn B, Skuban N, Niebler G. A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Reg Anesth Pain Med. 2023 Dec;48(12):601-607. doi: 10.1136/rapm-2022-104110. Epub 2023 Apr 19.

  PMID: 37076252 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Bupivacaine; Drug Implants

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Anne Arriaga

  Lotus Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: April 29, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)