Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

30. juni 2017 oppdatert av: INSYS Therapeutics Inc

A Randomized, Multicenter, Double-Blind, Double Dummy, Active Comparator, Dose-Ranging Study to Explore the Efficacy of SUBSYS® in Emergency Department Patients With Acute Pain

This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain.

After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician.

Adverse events will be collected for five days after initial enrollment.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85008
        • Maricopa Medical Center
    • California
      • Sylmar, California, Forente stater, 91342
        • Olive View-UCLA Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Kansas University Medical Center
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Wayne State University School of Medicine
      • Detroit, Michigan, Forente stater, 48021
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University
    • New York
      • Stony Brook, New York, Forente stater, 11794
        • Stony Brook University HSC
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University School of Medicine
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Pennsylvania Hospital
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Health System

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 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
  • Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
  • Has a pain score within protocol-specified parameters

Exclusion Criteria:

  • Has allergy to fentanyl or morphine
  • Has oxygen-dependent conditions or oxygen saturation <95%
  • Has planned or recent drug use outside protocol-specified parameters
  • Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results

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
Aktiv komparator: Morphine 6 mg
Placebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg
Legemiddel: Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
Andre navn:
  • Velferdstandard
  • IVM 6 mg
Legemiddel: Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
Andre navn:
  • PSS
Eksperimentell: Fentanyl 100 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg
Legemiddel: Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Andre navn:
  • SUBSYS®
  • FSS 100 µg
Legemiddel: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navn:
  • IVP
Eksperimentell: Fentanyl 200 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg
Legemiddel: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navn:
  • IVP
Legemiddel: Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Andre navn:
  • SUBSYS®
  • FSS 200 µg
Eksperimentell: Fentanyl 400 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg
Legemiddel: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navn:
  • IVP
Legemiddel: Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Andre navn:
  • SUBSYS®
  • FSS 400 µg

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of participants requiring additional doses of randomized pain medication
Tidsramme: at 30 minutes after initial treatment
at 30 minutes after initial treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of participants requiring additional doses of randomized pain medication at secondary time points
Tidsramme: within 120 minutes after initial treatment
within 120 minutes after initial treatment
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
Tidsramme: from baseline through 120 minutes after the initial dose of investigational product
from baseline through 120 minutes after the initial dose of investigational product
Number of Investigational Product (IP) administrations
Tidsramme: within 120 minutes after initial treatment
within 120 minutes after initial treatment
Time to onset of pain relief (in minutes) using the stopwatch method
Tidsramme: within 120 minutes after first treatment
within 120 minutes after first treatment
Richmond Agitation Sedation Scale (RASS) score
Tidsramme: within 120 minutes after first treatment
within 120 minutes after first treatment
Percentage of Participants requiring rescue medication
Tidsramme: during the 5-day study period
during the 5-day study period
Time until rescue medication was required
Tidsramme: during the 5-day study period
during the 5-day study period
Percentage of participants experiencing a treatment-related adverse event
Tidsramme: during the 5-day study period
during the 5-day study period
Percentage of participants with clinically significant changes in vital signs
Tidsramme: during the 5-day study period
during the 5-day study period

Samarbeidspartnere og etterforskere

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

Sponsor

INSYS Therapeutics Inc

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

Primær fullføring (Faktiske)

29. juni 2017

Datoer for studieregistrering

Først innsendt

12. mai 2014

Først innsendt som oppfylte QC-kriteriene

12. mai 2014

Først lagt ut (Anslag)

14. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • INS-14-022

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere