Status:
WITHDRAWN
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores
Lead Sponsor:
Adynxx, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
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 hi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04104919
Start Date
January 1 2021
End Date
February 1 2022
Last Update
July 13 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.