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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT06271265 |
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Date of registration:
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18/01/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
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Scientific title:
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A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery |
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Date of first enrolment:
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February 2024 |
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Target sample size:
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48 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06271265 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Contacts
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Name:
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Sarah Shaffer |
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Address:
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Telephone:
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973-451-4071 |
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Email:
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sarah.shaffer@pacira.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Parent/guardian able to speak, read, and understand the language of the ICF and
provide informed consent for the subject.
2. American Society of Anesthesiologists (ASA) Class 1-3.
3. Male or female subjects from 0 to less than 6 years of age on the day of surgery. For
Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the
subject's age should be 6 months to less than 2 years. For Part 3, the subject's age
should be 0 to less than 6 months.
4. Parent/guardian able to adhere to the study visit schedule and complete all study
assessments for the subject.
Exclusion Criteria:
1. History of hypersensitivity or idiosyncratic reactions or contradictions to
bupivacaine HCl or other amide-type local anesthetics or to opioid medications.
2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug
administration.
3. History of coagulopathies or immunodeficiency disorders.
4. Clinically significant medical or psychiatric disease that, in the opinion of the
investigator, indicates an increased vulnerability to study drugs and/or procedures.
5. History of pre-term birth (babies born before 37 weeks of pregnancy).
6. 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.
7. Concern about a subject's recent or potential exposure to COVID-19, or if the subject
is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms
(or other serious illness).
Age minimum:
0 Years
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: EXPAREL
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Drug: bupivacaine
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Primary Outcome(s)
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The following model-predicted PK endpoint will be determined:
[Time Frame: through 72 hours]
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Secondary Outcome(s)
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Incidence of adverse events of special interest (AESIs)
[Time Frame: 14 ± 3 days]
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Incidence of serious adverse events (SAEs)
[Time Frame: 14 ± 3 days]
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Incidence of treatment-emergent adverse events (TEAEs)
[Time Frame: 14 ± 3 days]
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Vitals change from Baseline:
[Time Frame: up to 4 postoperative days]
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Secondary ID(s)
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402-C-125
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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