Inguinal HerniaPhase 3NCT03262688
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
A Phase 3 study testing Bupivacaine HCl collagen-matrix implant and Bupivacaine HCl infiltration in people with Inguinal Hernia and Postoperative Pain, run by Innocoll at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- Bupivacaine HCl collagen-matrix implant and Bupivacaine HCl infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Jun 2017to 31 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 7 recruiting
- Recruiting
Cornerstone Research Institute
Altamonte Springs, Florida, 32701
Derrica Robinson, 407-729-1236, drobinson@cornerstonestudy.com
- Recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Debhanhi Gaylan, 540-314-1838, debhanhi@researchhd.com
- Recruiting
El Paso Children's Hospital
El Paso, Texas, 79905
Isaac Martinez, 915-244-0751, isaac@researchhd.com
- Recruiting
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
Jayme Carr, 832-524-7177, jayme@researchHD.com
- Withdrawn
The Woman's Hospital of Texas
Houston, Texas, 77054
- Recruiting
Alliance Research Centers
Laguna Hills, California, 92653
Tracy Bessette, 949-680-3490, tbessette@researchalliance.com
- Withdrawn
Medical Research Center
Miami, Florida, 33144
- Withdrawn
Elion & Volhard Pharmaceutical Research (E&V PR)
Miami, Florida, 33165
- Recruiting
Children's Hospital of Pittsburgh of UPMC (CHP-UPMC)
Pittsburgh, Pennsylvania, 15224
Denise McCarthy, 412-692-5585, mccarthydj@anes.upmc.edu
- Recruiting
Plano Surgical Hospital
Plano, Texas, 75093
Laura Kade, 410-614-5775, laura@researchhd.com
- Active, not recruiting
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to <17 Years of Age Following Open Inguinal Hernia Repair
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).
Read the detailed description
This is 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. Within 21 days of surgery, eligible subjects will be screened and have routine clinical laboratory testing and an electrocardiogram performed. Subjects will then undergo an open inguinal hernia repair under general anesthesia according to the investigator's standard surgical practice on day 1. 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. Within each age group, the study will be conducted in 3 parts.
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
- Inguinal Hernia, Postoperative Pain
- Being tested
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- Keywords
- INL-001, Bupivacaine, Collagen, Children, Pediatric, Inguinal hernia
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCl collagen-matrix implantDrug
Also called Xaracoll
Placement of the bupivacaine collagen-matrix in the surgical site
Bupivacaine HCl infiltrationDrug
Also called Marcaine
Infiltration of the surgical site
| Study group | Role | What they receive |
|---|---|---|
| INL-001 | Experimental | Bupivacaine HCl collagen-matrix implant Receives: Drug: Bupivacaine HCl collagen-matrix implant |
| Infiltration | Active comparator | Bupivacaine HCl infiltration Receives: Drug: Bupivacaine HCl infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Possibly related to bupivacaine toxicity
Measured: 30 days
Blood pressure (systolic/diastolic)
Signs/symptoms of bupivacaine toxicity
Measured: 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
Measured: 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
Measured: 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
Measured: Through Day 30
12-lead ECG
Screening only
Measured: 1 day at screening
3-lead ECG
Signs/symptoms of bupivacaine toxicity
Measured: Starting at Time 0 and continuing for at least 3 hours
Oxygen saturation levels
Pulse oximetry
Measured: Starting at Time 0 and continuing for at least 3 hours
Clinical laboratory testing
Collection of blood and urine samples
Measured: 1 day at screening
Wound healing assessments
Inspection of surgical wound site for signs of wound infection and dehiscence.
Measured: 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
Measured: 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.
Measured: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Secondary outcomes (6)
Cmax
Maximum observed plasma concentration
Measured: 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
Area under the plasma concentration time curve from Time zero to last quantifiable plasma concentration
Measured: 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-∞
Area under the plasma concentration time curve from Time zero to extrapolated through infinity
Measured: 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
Time to maximum obserbved plasma concentration
Measured: 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
Apparent first-order terminal elimination half-life
Measured: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
Pain intensity
Assessed using an 11-point NRS (for children 12 to <17 years of age), a FACES pain severity scale (children 4 through <12 years of age), or FLACC (children 2 and 3 years of age) immediately before the child receives any parenteral or oral rescue medication for breakthrough pain
Measured: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start16 Jun 2017
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Niebler, DO, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262688
- Sponsor's protocol ID
- INN-CB-020
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2017
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to <17 Years of Age Following Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03262688
- Acronym / sponsor ID
- INN-CB-020
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- INL-001, Bupivacaine, Collagen, Children, Pediatric, Inguinal hernia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is 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. Within 21 days of surgery, eligible subjects will be screened and have routine clinical laboratory testing and an electrocardiogram performed. Subjects will then undergo an open inguinal hernia repair under general anesthesia according to the investigator's standard surgical practice on day 1. 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. Within each age group, the study will be conducted in 3 parts.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| INL-001 | Experimental | Drug: Bupivacaine HCl collagen-matrix implantBupivacaine HCl collagen-matrix implant |
| Infiltration | Active comparator | Drug: Bupivacaine HCl infiltrationBupivacaine HCl infiltration |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine HCl collagen-matrix implantAlso: XaracollPlacement of the bupivacaine collagen-matrix in the surgical site | Drug | INL-001 |
| Bupivacaine HCl infiltrationAlso: MarcaineInfiltration of the surgical site | Drug | Infiltration |
Primary outcome
Adverse events
Time frame: 30 days
Possibly related to bupivacaine toxicity
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
Signs/symptoms of bupivacaine toxicity
Heart rate
Time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
Signs/symptoms of bupivacaine toxicity
Respiratory rate
Time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
Signs/symptoms of bupivacaine toxicity
Body temperature
Time frame: Through Day 30
Signs/symptoms of bupivacaine toxicity
12-lead ECG
Time frame: 1 day at screening
Screening only
3-lead ECG
Time frame: Starting at Time 0 and continuing for at least 3 hours
Signs/symptoms of bupivacaine toxicity
Oxygen saturation levels
Time frame: Starting at Time 0 and continuing for at least 3 hours
Pulse oximetry
Clinical laboratory testing
Time frame: 1 day at screening
Collection of blood and urine samples
Wound healing assessments
Time frame: Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30
Inspection of surgical wound site for signs of wound infection and dehiscence.
Nausea
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
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
Sedation
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.
6 secondary outcomes
Cmax
Time frame: 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
Time frame: 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-∞
Time frame: 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
Time frame: 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
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
Pain intensity
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwendolyn Niebler, DO study director
Innocoll
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine HCl collagen-matrix implant and Bupivacaine HCl infiltration in people with Inguinal Hernia and Postoperative Pain, run by Innocoll at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Head of Clinical Operations (484-406-5214, rsmall@innocoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 30 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.