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A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

21. april 2008 opdateret af: Pfizer

A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery

To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

490

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, 35213
        • Pfizer Investigational Site
      • Daphne, Alabama, Forenede Stater, 36526
        • Pfizer Investigational Site
      • Fairhope, Alabama, Forenede Stater, 36532
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36693
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36617
        • Pfizer Investigational Site
      • Sheffield, Alabama, Forenede Stater, 35660
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Pfizer Investigational Site
      • Glendale, Arizona, Forenede Stater, 85308
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85006
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85023
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85020
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85027
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85710
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85711
        • Pfizer Investigational Site
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Pfizer Investigational Site
      • Bakersfield, California, Forenede Stater, 93309
        • Pfizer Investigational Site
      • Bakersfield, California, Forenede Stater, 93311
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90017
        • Pfizer Investigational Site
      • Pasadena, California, Forenede Stater, 91109
        • Pfizer Investigational Site
      • Sacramento, California, Forenede Stater, 95817
        • Pfizer Investigational Site
      • San Jose, California, Forenede Stater, 95124
        • Pfizer Investigational Site
      • Woodland, California, Forenede Stater, 95695
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33176
        • Pfizer Investigational Site
      • Pensacola, Florida, Forenede Stater, 32504
        • Pfizer Investigational Site
    • Georgia
      • Blue Ridge, Georgia, Forenede Stater, 30513
        • Pfizer Investigational Site
      • Marietta, Georgia, Forenede Stater, 30060
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Pfizer Investigational Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • Pfizer Investigational Site
      • Germantown, Maryland, Forenede Stater, 20874
        • Pfizer Investigational Site
      • Rockville, Maryland, Forenede Stater, 20850
        • Pfizer Investigational Site
      • Silver Spring, Maryland, Forenede Stater, 20902
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103-3315
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-4998
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Pfizer Investigational Site
      • Columbia, South Carolina, Forenede Stater, 29203
        • Pfizer Investigational Site
      • Columbia, South Carolina, Forenede Stater, 29209
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
        • Pfizer Investigational Site
      • North Charleston, South Carolina, Forenede Stater, 29406
        • Pfizer Investigational Site
      • Summerville, South Carolina, Forenede Stater, 29485
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77024
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77055
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78224
        • Pfizer Investigational Site
      • Universal City, Texas, Forenede Stater, 78148
        • Pfizer Investigational Site
    • Utah
      • Sandy, Utah, Forenede Stater, 84070
        • Pfizer Investigational Site
      • Sandy, Utah, Forenede Stater, 84094
        • Pfizer Investigational Site
      • West Jordan, Utah, Forenede Stater, 84088
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23517
        • Pfizer Investigational Site
      • Suffolk, Virginia, Forenede Stater, 23434
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, Forenede Stater, 98055
        • Pfizer Investigational Site
      • Renton, Washington, Forenede Stater, 98058-5010
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Pfizer Investigational Site

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

Alle

Beskrivelse

Inclusion Criteria:

  • Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
  • Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

  • Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
  • Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
  • Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
  • Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation

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: Arm 2
Medicin: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
Medicin: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Aktiv komparator: Arm 1
Medicin: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
Medicin: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Placebo komparator: Arm 3
Medicin: placebo
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Opsummeret smerteintensitet (kategorisk) gennem 24 timer (SPI 24)
Tidsramme: Dag 2 og dag 3
Dag 2 og dag 3
Patients globale evaluering af undersøgelsesmedicin
Tidsramme: Dag 2 og dag 3
Dag 2 og dag 3

Sekundære resultatmål

Resultatmål
Tidsramme
Patients globale evaluering af undersøgelsesmedicin
Tidsramme: Dag 4 og dag 5
Dag 4 og dag 5
SPI 24 (kategorisk)
Tidsramme: Dag 4 og dag 5
Dag 4 og dag 5
Tidsspecifik PI (VAS)
Tidsramme: Dag 2 til 5
Dag 2 til 5
Tid mellem doser af undersøgelsesmedicin
Tidsramme: Dag 2 til 5
Dag 2 til 5
Time to first dose of rescue medication
Tidsramme: Days 2 to 5
Days 2 to 5
Percent of patients who took rescue medication on each study day
Tidsramme: Days 2 to 5
Days 2 to 5
Amount of rescue medication taken
Tidsramme: Days 2 to 5
Days 2 to 5
Worst PI (derived from the mBPI-SF)
Tidsramme: Days 2 to 5
Days 2 to 5
Average PI (derived from the mBPI-SF)
Tidsramme: Days 2 to 5
Days 2 to 5
Time-specific PI (categorical)
Tidsramme: Days 2 to 5
Days 2 to 5
SPI 24 (VAS)
Tidsramme: Days 2 to 5
Days 2 to 5

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 2002

Studieafslutning (Faktiske)

1. juli 2003

Datoer for studieregistrering

Først indsendt

31. marts 2008

Først indsendt, der opfyldte QC-kriterier

15. april 2008

Først opslået (Skøn)

18. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. april 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2008

Sidst verificeret

1. marts 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VALA-0513-145
  • A3471085

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 Smerte

Kliniske forsøg med valdecoxib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tunisia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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