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Local Anesthetic
Liposomal Bupivacaine for Healthy Volunteers
Phase 1
Recruiting
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-8 weeks
Awards & highlights
Study Summary
This trial is testing a new pain medication given as a single injection into the spinal fluid. The goal is to see if it is safe and tolerated by healthy volunteers, and to understand how it works in the body.
Who is the study for?
Healthy adults aged 18-50, with no history of severe headaches, back conditions, or chronic pain. Participants must not have allergies to study medications like bupivacaine and should not be on certain medications like corticosteroids before the trial. Women must not be pregnant or nursing.Check my eligibility
What is being tested?
The safety and effects of Liposomal Bupivacaine 13.3 are being tested when given as a single spinal injection to healthy volunteers. The trial will also measure how the drug moves through and affects the body.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, headache, nausea, dizziness, back pain, numbness or weakness in legs if it affects nerves in the spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent clearance (CL/F)
Apparent volume of distribution (Vd)
Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)
+3 moreSecondary outcome measures
Average duration of sensory block and motor block
Average time to onset of sensory block and motor block
Other outcome measures
Incidence of treatment-emergent AEs (TEAEs) through Day 9
Proportion of subjects who have any of the neurological events.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Liposomal Bupivacaine 13.3Experimental Treatment1 Intervention
Cohort 1 subjects will be dosed 2 mL (26.6 mg) of Liposomal Bupivacaine 13.3.
Cohort 2 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 3 mL (39.9 mg) of Liposomal Bupivacaine 13.3.
Cohort 3 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 4 mL (53.2 mg) of Liposomal Bupivacaine 13.3.
Group II: Bupivacaine ITActive Control1 Intervention
Cohort 1 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine.
Cohort 2 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine mixed with 1 mL of preservative free normal saline to create a total volume of solution administered of 3 mL.
Cohort 3 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg / 1 mL) of 0.75% bupivacaine mixed with 2 mL of preservative free normal saline to create a total volume of solution administered of 4 mL.
Group III: PlaceboPlacebo Group1 Intervention
Cohort 1 subjects randomized to the placebo arm will be dosed 2 mL of preservative free normal saline.
Cohort 2 subjects randomized to the placebo arm will be dosed 3 mL of preservative free normal saline.
Cohort 3 subjects randomized to the placebo arm will be dosed 4 mL of preservative free normal saline.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Pacira Pharmaceuticals, IncLead Sponsor
136 Previous Clinical Trials
13,979 Total Patients Enrolled
Matt Mandel, MDStudy DirectorPacira Pharmaceuticals, Inc
O'Dane BradyStudy DirectorPacira Pharmaceuticals, Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding risk or a blood clotting disorder with low platelets.I am not allergic or intolerant to the study's medications.My kidney or liver function is not impaired.I am between 18 and 50 years old and in good health.I have been diagnosed with migraine, cluster, or tension headaches.I haven't taken any opioid or NSAID medications in the last 3 days.I have used steroids or nerve pain medications up to 3 days before starting the study drug.I've been having headaches at least once a week for the last 3 months.I have a history of lower back issues or chronic low back pain.I have a painful condition that might need painkillers, which could affect my treatment's assessment.You are able to provide informed consent, adhere to the study schedule, and complete all study assessments.I am between 18 and 50 years old and in good health.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Liposomal Bupivacaine 13.3
- Group 3: Bupivacaine IT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration accepted EXPAREL for use in patients?
"Our team's assessment of EXPAREL’s safety is a 1, as this Phase 1 trial has not yet produced substantial evidence in support of its efficacy and safety."
Answered by AI
Are there any vacancies in this clinical investigation for potential participants?
"As per the details on clinicaltrials.gov, this medical study has concluded its search for participants as of September 26th 2022. Though no longer recruiting, there are still 840 other trials accepting clients right now."
Answered by AI
To whom does this trial extend its eligibility requirements?
"This clinical trial seeks 20 test subjects between 18 and 50 years old who are generally healthy. In addition, the participant must meet all of the following criteria: American Society of Anesthesiologists physical status 1, able to provide informed consent, willing follow through with scheduling requirements, and complete all study assessments."
Answered by AI
Is participation in this medical study open to people over 20 years old?
"For this study, participants must be aged 18 to 50. In addition, there are 50 studies for minors and 372 trials for people over 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Duke University
What portion of applicants met pre-screening criteria?
Met criteria
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