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

8. september 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

331

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

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

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 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: IV acetaminophen 1 g/100 mL solution
Legemiddel: IV Acetaminophen
Intravenous acetaminophen 1 g/100 mL
Andre navn:
  • IV Acetaminophen (IV APAP)
Placebo komparator: IV Placebo 100 mL solution
Legemiddel: IV Placebo 100 mL solution
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Andre navn:
  • IV Placebo (non-active product)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

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

Sponsor

Mallinckrodt

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

1. november 2006

Primær fullføring (Faktiske)

1. september 2007

Studiet fullført (Faktiske)

1. september 2007

Datoer for studieregistrering

Først innsendt

14. november 2006

Først innsendt som oppfylte QC-kriteriene

14. november 2006

Først lagt ut (Anslag)

15. november 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CPI-APA-301

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