search
Back to results

Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores

Primary Purpose

Pain, Postoperative

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Brivoligide Injection 660 mg/6 mL
Placebo 6 mL
Sponsored by
Adynxx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Mastectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Score of 16 or greater on the PCS scale
  • Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement
  • American Society of Anesthesiologists Physical Status Classification System ≤ 3
  • Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator
  • Body mass index of 18-45 kg/m2
  • Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization
  • Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures

Exclusion Criteria:

  • Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies
  • Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery
  • Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug
  • Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study
  • Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
  • Current neurologic disorder, which could confound the assessment of pain
  • Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator
  • Women who are pregnant or nursing
  • Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study
  • Previous participation in any study involving brivoligide injection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Brivoligide Injection 660 mg/6 mL

    Placebo 6 mL

    Arm Description

    Subjects randomized to the brivoligide treatment group will receive a single 660 mg/6 mL intrathecal administration of brivoligide injection while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.

    Subjects randomized to the placebo group will receive a single 6 mL intrathecal administration of placebo while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.

    Outcomes

    Primary Outcome Measures

    Pain with general movement involving the chest and upper body
    Least Squares (LS) Mean pain rating with general movement involving the chest and upper body on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)

    Secondary Outcome Measures

    Pain at rest
    Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Pain with deep full inspiration and forceful effective cough
    Least Squares (LS) Mean pain rating with deep full inspiration and forceful effective cough on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Pain with ipsilateral arm abduction
    Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Total use of postoperative opioid medications
    Total use (median) of postoperative opioid medications (morphine equivalents)
    Total use of postoperative opioid medications
    Total use (median) of postoperative opioid medications (morphine equivalents)
    Change from baseline for the BREAST-Q
    Change from baseline to Day 21 for the BREAST-Q

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    July 9, 2020
    Sponsor
    Adynxx, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04104919
    Brief Title
    Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores
    Official Title
    A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study Initiation delayed due to COVID 19
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Adynxx, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.
    Detailed Description
    Potential subjects will be prescreened for PCS score; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1). Subjects will receive study drug just prior to anesthesia induction. Study assessments will be entered by subjects in the electronic diary from Day 1 through Day 21. Follow-up visits will occur on Days 7 and 21 (± 2 days).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Mastectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brivoligide Injection 660 mg/6 mL
    Arm Type
    Experimental
    Arm Description
    Subjects randomized to the brivoligide treatment group will receive a single 660 mg/6 mL intrathecal administration of brivoligide injection while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.
    Arm Title
    Placebo 6 mL
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects randomized to the placebo group will receive a single 6 mL intrathecal administration of placebo while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Brivoligide Injection 660 mg/6 mL
    Other Intervention Name(s)
    AYX1 Injection 660 mg/6 mL
    Intervention Description
    Single preoperative intrathecal injection
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo 6 mL
    Intervention Description
    Single preoperative intrathecal injection
    Primary Outcome Measure Information:
    Title
    Pain with general movement involving the chest and upper body
    Description
    Least Squares (LS) Mean pain rating with general movement involving the chest and upper body on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Time Frame
    Day 3 to Day 14
    Secondary Outcome Measure Information:
    Title
    Pain at rest
    Description
    Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Time Frame
    Day 3 to Day 14
    Title
    Pain with deep full inspiration and forceful effective cough
    Description
    Least Squares (LS) Mean pain rating with deep full inspiration and forceful effective cough on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Time Frame
    Day 3 to Day 14
    Title
    Pain with ipsilateral arm abduction
    Description
    Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
    Time Frame
    Day 14 to Day 21
    Title
    Total use of postoperative opioid medications
    Description
    Total use (median) of postoperative opioid medications (morphine equivalents)
    Time Frame
    Day 3 to Day 14
    Title
    Total use of postoperative opioid medications
    Description
    Total use (median) of postoperative opioid medications (morphine equivalents)
    Time Frame
    Day 1 through Day 21
    Title
    Change from baseline for the BREAST-Q
    Description
    Change from baseline to Day 21 for the BREAST-Q
    Time Frame
    Screening to Day 21

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Score of 16 or greater on the PCS scale Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement American Society of Anesthesiologists Physical Status Classification System ≤ 3 Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator Body mass index of 18-45 kg/m2 Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures Exclusion Criteria: Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization Current neurologic disorder, which could confound the assessment of pain Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator Women who are pregnant or nursing Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study Previous participation in any study involving brivoligide injection

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores

    We'll reach out to this number within 24 hrs