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

9. juli 2020 oppdatert av: Adynxx, Inc.

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

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Brivoligide Injection 660 mg/6 mL
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.
Legemiddel: Brivoligide injeksjon 660 mg/6 ml
Enkel preoperativ intratekal injeksjon
Andre navn:
  • AYX1 Injeksjon 660 mg/6 ml
Placebo komparator: Placebo 6 mL
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.
Legemiddel: Placebo 6 ml
Enkel preoperativ intratekal injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain with general movement involving the chest and upper body
Tidsramme: Day 3 to Day 14
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)
Day 3 to Day 14

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain at rest
Tidsramme: Day 3 to Day 14
Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Day 3 to Day 14
Pain with deep full inspiration and forceful effective cough
Tidsramme: Day 3 to Day 14
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)
Day 3 to Day 14
Pain with ipsilateral arm abduction
Tidsramme: Day 14 to Day 21
Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Day 14 to Day 21
Total use of postoperative opioid medications
Tidsramme: Day 3 to Day 14
Total use (median) of postoperative opioid medications (morphine equivalents)
Day 3 to Day 14
Total use of postoperative opioid medications
Tidsramme: Day 1 through Day 21
Total use (median) of postoperative opioid medications (morphine equivalents)
Day 1 through Day 21
Change from baseline for the BREAST-Q
Tidsramme: Screening to Day 21
Change from baseline to Day 21 for the BREAST-Q
Screening to Day 21

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Adynxx, Inc.

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2021

Primær fullføring (Forventet)

1. januar 2022

Studiet fullført (Forventet)

1. februar 2022

Datoer for studieregistrering

Først innsendt

24. september 2019

Først innsendt som oppfylte QC-kriteriene

24. september 2019

Først lagt ut (Faktiske)

26. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ADYX-006
  • 1UG3DA048375-01 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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