Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair

NCT03262688 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: INN-CB-020
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 11

Brief Summary

A multicenter, single-dose study in children 12 to \<17 years of age, 6 to \<12 years of age, and 2 to \<6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to \<17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to \<17 years, 6 to \<12 years, 2 to \<6 years).

Conditions

Inguinal Hernia; Postoperative Pain

Keywords

INL-001; Bupivacaine; Collagen; Children; Pediatric; Inguinal hernia

Outcome Measures

Primary Outcomes (12)

• Adverse events

  Possibly related to bupivacaine toxicity

  30 days

• Blood pressure (systolic/diastolic)

  Signs/symptoms of bupivacaine toxicity

  Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0

• Heart rate

  Signs/symptoms of bupivacaine toxicity

  Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0

• Respiratory rate

  Signs/symptoms of bupivacaine toxicity

  Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0

• Body temperature

  Signs/symptoms of bupivacaine toxicity

  Through Day 30

• 12-lead ECG

  Screening only

  1 day at screening

• 3-lead ECG

  Signs/symptoms of bupivacaine toxicity

  Starting at Time 0 and continuing for at least 3 hours

• Oxygen saturation levels

  Pulse oximetry

  Starting at Time 0 and continuing for at least 3 hours

• Clinical laboratory testing

  Collection of blood and urine samples

  1 day at screening

• Wound healing assessments

  Inspection of surgical wound site for signs of wound infection and dehiscence.

  Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30

• Nausea

  Measured using a categorical scoring system (none = 0, mild = 1, moderate = 2, and severe = 3). Nausea scores will also be recorded immediately before the use of rescue antiemetics

  1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0

• Sedation

  Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.

  1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0

Secondary Outcomes (6)

• Cmax

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0.

• AUC0-last

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0

• AUC0-∞

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0

• Tmax

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0

• t1/2

  0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0

Study Arms (2)

INL-001

EXPERIMENTAL

Bupivacaine HCl collagen-matrix implant

Drug: Bupivacaine HCl collagen-matrix implant

Infiltration

ACTIVE COMPARATOR

Bupivacaine HCl infiltration

Drug: Bupivacaine HCl infiltration

Interventions

Bupivacaine HCl collagen-matrix implant DRUG

Placement of the bupivacaine collagen-matrix in the surgical site

Also known as: Xaracoll

INL-001

Bupivacaine HCl infiltration DRUG

Infiltration of the surgical site

Also known as: Marcaine

Infiltration

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be a male or female 2 to \<17 years of age.
• Be eligible for an elective open inguinal hernia repair that will be performed according to standard surgical technique under general anesthesia.
• Be premenarche or have a serum confirmed negative pregnancy test at screening and a negative urine pregnancy test before surgery on day 1, if an adolescent female of childbearing potential.
• Be willing and able to cooperate with all the requirements of the study.
• Be able to speak and understand English or Spanish.
• Have a legally authorized representative (eg, parent, guardian) who is able to read, speak, and understand English or Spanish and who will voluntarily sign and date a parental permission/informed consent form that is approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
• Be willing to sign an assent (if appropriate dependent upon the child's age, understanding, and IRB requirements), before the conduct of any study procedure.

You may not qualify if:

• Has a known hypersensitivity to amide local anesthetics, bovine products, or to inactive ingredients of the study drugs.
• Requires any additional surgical procedures, either related or unrelated to the scheduled surgery (ie, open inguinal hernia surgery), during the same hospitalization.
• Requires epidural or spinal blockade perioperatively.
• Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.
• Has undergone major surgery within 3 months of the scheduled surgery or plans to undergo another surgical procedure within the 30-day postoperative period.
• Has known or suspected history of drug abuse or misuse or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.
• Has participated in a clinical trial (investigational or marketed product) within 30 days before surgery.
• Has any clinically significant medical history or condition (eg, unstable cardiac, neurological, immunological, renal, hepatic, or hematological disease or any other condition) that in the opinion of the investigator, substantially increases the risk associated with the subject's participation in the protocol or compromises the scientific objectives of the study.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (11)

Alliance Research Centers

Laguna Hills, California, 92653, United States

RECRUITING

Cornerstone Research Institute

Altamonte Springs, Florida, 32701, United States

RECRUITING

Medical Research Center

Miami, Florida, 33144, United States

WITHDRAWN

Elion & Volhard Pharmaceutical Research (E&V PR)

Miami, Florida, 33165, United States

WITHDRAWN

Children's Hospital of Pittsburgh of UPMC (CHP-UPMC)

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

El Paso Children's Hospital

El Paso, Texas, 79905, United States

RECRUITING

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

RECRUITING

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

WITHDRAWN

Plano Surgical Hospital

Plano, Texas, 75093, United States

RECRUITING

Jean Brown Research

Salt Lake City, Utah, 84124, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gwendolyn Niebler, DO

  Innocoll

  STUDY DIRECTOR

Central Study Contacts

Nina Head of Clinical Operations

CONTACT

484-406-5214; rsmall@innocoll.com

Nina Head of Clinical Research, MD

CONTACT

484-406-5205; nskuban@innocoll.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant, legal guardian and study personnel involved in the assessment of efficacy and safety are blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 25, 2017
• Study Start: June 16, 2017
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)