Recruiting
Phase 3

INL-001

Sponsor:

Innocoll

Code:

NCT03262688

Conditions

Inguinal Hernia

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 2 - 16

Healthy Volunteers: Not accepted

Interventions

Bupivacaine HCl collagen-matrix implant

Bupivacaine HCl infiltration

Study Details

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

Study ID

NCT03262688

Start date

Jun 16, 2017

Status verified date

Jul, 2021

Completion date

Jan 31, 2024

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

159 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INL-001

Bupivacaine HCl collagen-matrix implant

active comparator: Infiltration

Bupivacaine HCl infiltration

Interventions

Bupivacaine HCl collagen-matrix implant

Placement of the bupivacaine collagen-matrix in the surgical site

Bupivacaine HCl infiltration

Infiltration of the surgical site

Primary outcome measure

  • Adverse events [ Time Frame: 30 days ]
  • Blood pressure (systolic/diastolic) [ Time Frame: Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0 ]
  • Heart rate [ Time Frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0 ]
  • Respiratory rate [ Time Frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0 ]
  • Body temperature [ Time Frame: Through Day 30 ]
  • 12-lead ECG [ Time Frame: 1 day at screening ]
  • 3-lead ECG [ Time Frame: Starting at Time 0 and continuing for at least 3 hours ]
  • Oxygen saturation levels [ Time Frame: Starting at Time 0 and continuing for at least 3 hours ]
  • Clinical laboratory testing [ Time Frame: 1 day at screening ]
  • Wound healing assessments [ Time Frame: Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30 ]
  • Nausea [ Time Frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0 ]
  • Sedation [ Time Frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0 ]

Central Contacts and Locations

Central contacts

Nina Head of Clinical Operations

484-406-5214rsmall@innocoll.com

Nina Head of Clinical Research, MD

484-406-5205nskuban@innocoll.com

Locations

Alliance Research Centers

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Tracy Bessette

949-680-3490tbessette@researchalliance.com

Cornerstone Research Institute

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Derrica Robinson

407-729-1236drobinson@cornerstonestudy.com

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Denise McCarthy

412-692-5585mccarthydj@anes.upmc.edu

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Debhanhi Gaylan

540-314-1838debhanhi@researchhd.com

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Isaac Martinez

915-244-0751isaac@researchhd.com

Memorial Hermann Memorial City Medical Center

Recruiting

Houston, Texas, United States, 77024

Contacts

Jayme Carr

832-524-7177jayme@researchHD.com

Plano Surgical Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Laura Kade

410-614-5775laura@researchhd.com

More Information

Sponsor

Innocoll

Last update posted

Jul 30, 2021

Last verified

Jul, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innocoll on 2021-07-30.