4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Ana

Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Ana

Study Description
Brief Summary:
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.

Condition or disease Intervention/treatment Phase
Bunion Metatarsophalangeal Fusion Midfoot Fusion Hindfoot Fusion Total Ankle Arthroplasty Forefoot Surgery Drug: EXPAREL 13.3Mg/mL Suspension for Injection Drug: Bupivacaine Hydrochloride Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Cohort 1, Group 1

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.

EXPAREL will be mixed with Bupivacaine

Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

 Drug: EXPAREL 13.3Mg/mL Suspension for Injection
Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Active Comparator: Cohort 1, Group 2

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.

Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

 Drug: Bupivacaine Hydrochloride
Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
Experimental: Cohort 2, Group 1

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.

EXPAREL will be mixed with Bupivacaine

Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

 Drug: EXPAREL 13.3Mg/mL Suspension for Injection
Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Active Comparator: Cohort 2, Group 2

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.

Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

 Drug: Bupivacaine Hydrochloride
Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
Outcome Measures
Primary Outcome Measures :
  1. Magnitude of analgesic effect [ Time Frame: 0 hours to 96 hours ]
    Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.


Secondary Outcome Measures :
  1. Total Postsurgical Opioid Consumption [ Time Frame: 0 hours to 96 hours ]
    Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy adult male or female volunteers ages 18 or older
  2. American Society of Anesthesiologists (ASA) physical status 1, 2 or 3.
  3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
  4. Body Mass Index ≥18 and ≤40 kg/m2

Exclusion Criteria:

  1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
  2. Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
  3. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
  4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  5. 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
  6. Previous participation in EXPAREL study
  7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
  8. Currently pregnant, nursing, or planning to become pregnant during the study
  9. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
  10. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
  11. Inadequate sensory function on the foot (monofilament test)

  12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

    In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:

  13. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date August 13, 2020
Estimated Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020) 		Magnitude of analgesic effect [ Time Frame: 0 hours to 96 hours ]
Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		Magnitude of analgesic effect [ Time Frame: 24 hours to 96 hours ]
Area under the Curve of the NRS Pain intensity scores from 24 hours to 96 hours post-surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020) 		Total Postsurgical Opioid Consumption [ Time Frame: 0 hours to 96 hours ]
Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Total Postsurgical Opioid Consumption [ Time Frame: 24 hours to 96 hours ]
    Total Postsurgical opioid consumption from 24 hours to 96 hours post-surgery
  • Time To first Opioid Rescue [ Time Frame: 14 Days post surgery ]
    Time to first Opioid rescue post surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
Official Title  ICMJE A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
Brief Summary This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • Bunion
  • Metatarsophalangeal Fusion
  • Midfoot Fusion
  • Hindfoot Fusion
  • Total Ankle Arthroplasty
  • Forefoot Surgery
Intervention  ICMJE
  • Drug: EXPAREL 13.3Mg/mL Suspension for Injection
    Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
  • Drug: Bupivacaine Hydrochloride
    Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
Study Arms  ICMJE
  • Experimental: Cohort 1, Group 1

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.

    EXPAREL will be mixed with Bupivacaine

    Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

    Intervention: Drug: EXPAREL 13.3Mg/mL Suspension for Injection
  • Active Comparator: Cohort 1, Group 2

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.

    Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

    Intervention: Drug: Bupivacaine Hydrochloride
  • Experimental: Cohort 2, Group 1

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.

    EXPAREL will be mixed with Bupivacaine

    Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

    Intervention: Drug: EXPAREL 13.3Mg/mL Suspension for Injection
  • Active Comparator: Cohort 2, Group 2

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.

    Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

    Intervention: Drug: Bupivacaine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 11, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		81
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adult male or female volunteers ages 18 or older
  2. American Society of Anesthesiologists (ASA) physical status 1, 2 or 3.
  3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
  4. Body Mass Index ≥18 and ≤40 kg/m2

Exclusion Criteria:

  1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
  2. Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
  3. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
  4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  5. 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
  6. Previous participation in EXPAREL study
  7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
  8. Currently pregnant, nursing, or planning to become pregnant during the study
  9. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
  10. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
  11. Inadequate sensory function on the foot (monofilament test)

  12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

    In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:

  13. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954639
Other Study ID Numbers  ICMJE 402-C-332
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pacira Pharmaceuticals, Inc
Study Sponsor  ICMJE Pacira Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pacira Pharmaceuticals, Inc
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP