Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

8. september 2016 opdateret af: Mallinckrodt

Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery

This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

331

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249
        • University of Alabama (Anesthesiology)
      • Sheffield, Alabama, Forenede Stater, 35660
        • Helen Keller Hospital
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Precision Trials
      • Phoenix, Arizona, Forenede Stater, 85023
        • Arizona Research Center, Inc (JC Lincoln)
      • Phoenix, Arizona, Forenede Stater, 85023
        • Arizona Research Center, Inc. (Arrowhead)
    • California
      • Arcadia, California, Forenede Stater, 91007
        • Arcadia Methodist Hospital
      • Glendale, California, Forenede Stater, 91206
        • Glendale Adventist Medical Center
      • Pasadena, California, Forenede Stater, 91105
        • Huntington Memorial Hospital
      • San Clemente, California, Forenede Stater, 92672
        • Accurate Clinical Trials, Inc.
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33414
        • Visions Clinical Research
      • Fort Pierce, Florida, Forenede Stater, 34950
        • G and G Research, Inc.
      • Holly Hill, Florida, Forenede Stater, 32117
        • Century Clinical Research, Inc
      • Inverness, Florida, Forenede Stater, 34452
        • Nature Coast Clinical Research
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami School of Medicine Dept. of Anesthesiology
      • Vero Beach, Florida, Forenede Stater, 32960
        • Treasure Coast Obstetrics and Gynecology
    • Michigan
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Anesthesia
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • St. Peters University Hospital, Anesthesiology
    • New York
      • Albany, New York, Forenede Stater, 11208
        • Albany Medical College Dept. of Anesthesiology
      • Bronx, New York, Forenede Stater, 10461
        • Jacobi Medical Center (Albert Einstein College of Medicine)
      • New York, New York, Forenede Stater, 10021
        • Weill Medical College
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook Anesthesiology Health Sciences Cente
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Allegheny Pain Managment
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Dept. of Anesthesiology
    • Texas
      • Houston, Texas, Forenede Stater, 77024
        • Memorial Herman/Memorial City Hospital
      • Houston, Texas, Forenede Stater, 77024
        • Texas Woman's Hospital

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
  • 18-75 years of age
  • Body Mass Index (BMI) between 19-45
  • American Society of Anesthesiologists (ASA) risk class of I, II, III
  • Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
  • Moderate to Severe pain at rest

Exclusion Criteria:

  • Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
  • Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
  • Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
  • Known history of alcohol or drug abuse or misuse
  • Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
  • Has significant medical disease(s), or conditions that may contraindicate participation in the study
  • Has participated in another clinical trial within 30 days of surgery

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IV acetaminophen 1 g/100 mL solution
Medicin: IV Acetaminophen
Intravenous acetaminophen 1 g/100 mL
Andre navne:
  • IV Acetaminophen (IV APAP)
Placebo komparator: IV Placebo 100 mL solution
Medicin: IV Placebo 100 mL solution
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Andre navne:
  • IV Placebo (non-active product)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
Tidsramme: Baseline (just prior to the first dose) through 24 hours
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours.
Baseline (just prior to the first dose) through 24 hours
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
Tidsramme: Baseline (just prior to the first dose) through 48 hours
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours.
Baseline (just prior to the first dose) through 48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Tidsramme: First dose through 7 day follow up
Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)
First dose through 7 day follow up
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
Tidsramme: 32 days following first dose of study medication.

Number of subjects who reported SAEs during the study.

A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:

Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event
32 days following first dose of study medication.

Samarbejdspartnere og efterforskere

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

Sponsor

Mallinckrodt

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

Studiestart

1. november 2006

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. september 2007

Datoer for studieregistrering

Først indsendt

14. november 2006

Først indsendt, der opfyldte QC-kriterier

14. november 2006

Først opslået (Skøn)

15. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CPI-APA-301

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 Postoperativ smerte

Kliniske forsøg med IV Acetaminophen

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ecuador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner