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

NCT04785638 | Completed Phase 3 FDA Drug

• 1 other identifier: INN-CB-025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

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-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

Conditions

Pain, Postoperative; Hernia, Ventral; Abdominoplasty; Hysterectomy; Colectomy; Reduction Mammoplasty

Keywords

Pain; Analgesia; Postoperative; Hernia; Abdominoplasty; Tummy tuck; Hysterectomy; Colectomy; Bupivacaine; Postsurgical; Implant; Safety; Efficacy; Pharmacokinetic; Opioid; Nonopioid; Post-operative; Post-surgical; Surgery; Soft tissue; Open-label; Phase 3; Local anesthetic

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability

  The primary objective of the study is to evaluate the safety and tolerability of the INL-001 implant in patients. Measured by frequency and incidents of adverse events.

  Day 1 through Day 30

Secondary Outcomes (7)

• Cmax

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours

• Tmax

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours

• Tlag

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours

• t½ Terminal Half life

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours

• λz

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours

Other Outcomes (10)

• SPI24

  0 to 24 hours

• SPI48

  0 to 48 hours

• SPI72

  0 to 72 Hours

Study Arms (1)

INL-001 (bupivacaine hydrochloride) implant

EXPERIMENTAL

INL-001 (bupivacaine hydrochloride) implant

Combination Product: INL-001 (bupivacaine hydrochloride) implant

Interventions

INL-001 (bupivacaine hydrochloride) implant COMBINATION_PRODUCT

INL-001 (bupivacaine hydrochloride) implant

Also known as: XARACOLL (bupivacaine hydrochloride) Implant

INL-001 (bupivacaine hydrochloride) implant

Eligibility Criteria

• Age: 18 Years - 75 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.
• 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.

Sponsors & Collaborators

• Innocoll: lead

Study Sites (8)

North Alabama Medical Center

Florence, Alabama, 35630, United States

Location

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

Daneshvari Solanki

Houston, Texas, 77004, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Memorial Hermann

Houston, Texas, 77089, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Ventral; Pain; Agnosia; Hernia

Interventions

Bupivacaine; Drug Implants

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Pathological Conditions, Anatomical; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: April 14, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)