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

30. juni 2017 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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
Medicin: Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
Andre navne:
  • Standard for pleje
  • IVM 6 mg
Medicin: Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
Andre navne:
  • PSS
Eksperimentel: 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
Medicin: Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Andre navne:
  • SUBSYS®
  • FSS 100 µg
Medicin: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navne:
  • IVP
Eksperimentel: 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
Medicin: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navne:
  • IVP
Medicin: Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Andre navne:
  • SUBSYS®
  • FSS 200 µg
Eksperimentel: 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
Medicin: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Andre navne:
  • IVP
Medicin: Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Andre navne:
  • SUBSYS®
  • FSS 400 µg

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

INSYS Therapeutics Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Primær færdiggørelse (Faktiske)

29. juni 2017

Datoer for studieregistrering

Først indsendt

12. maj 2014

Først indsendt, der opfyldte QC-kriterier

12. maj 2014

Først opslået (Skøn)

14. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INS-14-022

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut smerte

Kliniske forsøg med Morphine 6 mg

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Sponsorer og samarbejdspartnere

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Betingelser

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Sponsor / samarbejdspartnere

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