Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
NCT ID: NCT03262688
Last Updated: 2021-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
159 participants
INTERVENTIONAL
2017-06-16
2024-01-31
Brief Summary
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Detailed Description
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Children in each age group who are randomized to INL-001 will receive approximately less than or equal to 2.5 mg/kg of INL-001. Study drug will be administered prior to wound closure. The INL-001 implant will be cut before placement into the surgical site using sterile technique. Children randomized to 0.25% bupivacaine HCl injection will receive 2.5 mg/kg according to standard practice.
After completion of the surgical procedure, all subjects will remain in the post-anesthesia care unit for at least 3 hours and will be continuously monitored for safety. At the discretion of the investigator, subjects may receive rescue medication (opioid or nonopioid) upon request for the management of breakthrough pain and may receive an antiemetic for the management of nausea or vomiting. After the initial 3-hour period, subjects who are deemed stable may be discharged to the hospital ward. Subjects will remain housed in the hospital ward for at least 48 hours. Blood samples will be collected for pharmacokinetic analysis from a subset of 8 children in each age group after INL-001 is implanted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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INL-001
Bupivacaine HCl collagen-matrix implant
Bupivacaine HCl collagen-matrix implant
Placement of the bupivacaine collagen-matrix in the surgical site
Infiltration
Bupivacaine HCl infiltration
Bupivacaine HCl infiltration
Infiltration of the surgical site
Interventions
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Bupivacaine HCl collagen-matrix implant
Placement of the bupivacaine collagen-matrix in the surgical site
Bupivacaine HCl infiltration
Infiltration of the surgical site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
16 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Innocoll
INDUSTRY
Responsible Party
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Principal Investigators
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Gwendolyn Niebler, DO
Role: STUDY_DIRECTOR
Innocoll
Locations
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Alliance Research Centers
Laguna Hills, California, United States
Cornerstone Research Institute
Altamonte Springs, Florida, United States
Medical Research Center
Miami, Florida, United States
Elion & Volhard Pharmaceutical Research (E&V PR)
Miami, Florida, United States
Children's Hospital of Pittsburgh of UPMC (CHP-UPMC)
Pittsburgh, Pennsylvania, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
El Paso Children's Hospital
El Paso, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INN-CB-020
Identifier Type: -
Identifier Source: org_study_id
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