E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the pharmacokinetics of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-male or female subjects 12 to less than 17 years of age on the day of surgery -ASA Class 1-3 -BMI at screening within the 20th to 80th percentile for age and sex -negative pregnancy test |
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E.4 | Principal exclusion criteria |
-contraindication to bupivacaine or other amide-type local anesthetics or opioid medication -administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration -subjects with coagulopathies or immunodeficiency disorders -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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
15±5 min, 30±5 min, 45±5 min, 1-1.25 h, 2-3h, 10-18 h, 24-36 h, 42-60 h |
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E.5.2 | Secondary end point(s) |
-change from baseline (collected at screening) in vital signs (temperature, resting heart rate, respiratory rate, and blood pressure) at each assessed timepoint. -Summary of neurological assessments (proportion of subjects who are oriented, and proportion of subjects who have any of the neurologic events). -Change from baseline (collected at screening) in clinical laboratory data at each assessed timepoint. -Incidence of TEAEs and SAEs through Day 30. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(Vital Signs) screening; 4, 8, 12, 24, 36, 48, 60, 72, and 96 hours; at hospital discharge; and on Day 30 (Neurological Assessment) Screening; 4, 8, 12, 24, 36, 48, 60, 72, and 96 hours; at hospital discharge; and on Day 30 (Clinical Laboratory Tests) screening and at 96 hours (Adverse events) from the time the ICF is signed/assent obtained through Day 30 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 10 |