Postoperative Pain ManagementPhase 1NCT03485014
Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
A Phase 1 study testing Exparel in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Exparel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 12 Feb 2019
- Phase
- Phase 1
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects whose parent(s) or guardian(s) has/have signed and dated an informed consent form for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
- American Society of Anesthesiologists (ASA) Class 1-3.
- Male or female subjects 12 to less than 17 years of age on the day of surgery.
- Body mass index (BMI) at screening within the 20th to 80th percentile for age and sex.
- A pregnancy test for female subjects of childbearing potential will be conducted in the preoperative holding area according to the study site's standard of care. A negative result for the pregnancy test must be available prior to the start of surgery.
- Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes in order to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
- Subjects must be able to adhere to the study visit schedule and complete all study assessments.
Who cannot join
- Contraindication to bupivacaine or other amide-type local anesthetics or to opioid medication.
- Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
- Subjects with coagulopathies or immunodeficiency disorders.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- In addition, the subject will be ineligible to receive study drug if the following criterion is met during surgery:
- Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Local Administration of EXPAREL for Postsurgical Analgesia in Pediatric Subjects 12 to Less Than 17 Years of Age
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Read the detailed description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXAPREL when administered intraoperatively at the end of surgery via local infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal surgeries are planned for enrollment.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.
Subjects will undergo their pre-planned spinal surgeries per the institution's standard of care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg intraoperatively at the end of surgery via local infiltration into the surgical site. There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician.
A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who received study drug.
- Conditions
- Postoperative Pain Management
- Being tested
- Exparel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
EXPAREL 4 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Experimental: EXPAREL 4 mg/kg | Experimental | Single dose of EXPAREL 4 mg/kg Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of EXPAREL concentration
Area under the concentration curve for EXPAREL
Measured: 0-96 hours
Secondary outcomes (1)
Incidence of treatment-emergent adverse events and serious adverse events
Incidence of treatment-emergent adverse events and serious adverse events through 30 days
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start10 Apr 2018
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert T Ballock, MD, Principal investigator, The Cleveland ClinicIgor Grachev, MD, PhD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485014
- Sponsor's protocol ID
- 402-C-120
- Status last verified
- Aug 2023
- First submitted
- 26 Mar 2018
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Local Administration of EXPAREL for Postsurgical Analgesia in Pediatric Subjects 12 to Less Than 17 Years of Age
- ClinicalTrials.gov ID
- NCT03485014
- Acronym / sponsor ID
- 402-C-120
- Conditions
- Postoperative Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 2 Apr 2018 (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.
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Detailed description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXAPREL when administered intraoperatively at the end of surgery via local infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal surgeries are planned for enrollment.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.
Subjects will undergo their pre-planned spinal surgeries per the institution's standard of care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg intraoperatively at the end of surgery via local infiltration into the surgical site. There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician.
A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who received study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: EXPAREL 4 mg/kg | Experimental | Drug: ExparelSingle dose of EXPAREL 4 mg/kg |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects whose parent(s) or guardian(s) has/have signed and dated an informed consent form for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
- American Society of Anesthesiologists (ASA) Class 1-3.
- Male or female subjects 12 to less than 17 years of age on the day of surgery.
- Body mass index (BMI) at screening within the 20th to 80th percentile for age and sex.
- A pregnancy test for female subjects of childbearing potential will be conducted in the preoperative holding area according to the study site's standard of care. A negative result for the pregnancy test must be available prior to the start of surgery.
Key exclusion criteria (6 listed)
- Contraindication to bupivacaine or other amide-type local anesthetics or to opioid medication.
- Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
- Subjects with coagulopathies or immunodeficiency disorders.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- In addition, the subject will be ineligible to receive study drug if the following criterion is met during surgery:
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 |
|---|---|---|
| ExparelEXPAREL 4 mg/kg | Drug | Experimental: EXPAREL 4 mg/kg |
Primary outcome
AUC of EXPAREL concentration
Time frame: 0-96 hours
Area under the concentration curve for EXPAREL
1 secondary outcome
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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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.
Robert T Ballock, MD principal investigator
The Cleveland Clinic
Igor Grachev, MD, PhD study director
Pacira Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exparel in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 1 site 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 6 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: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of EXPAREL concentration (time frame: 0-96 hours). 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 2 Aug 2023.