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Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

13. juli 2012 opdateret af: Pfizer

Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection

This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

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
    • California
      • Cypress, California, Forenede Stater, 90630
        • Pfizer Investigational Site
      • Westlake Village, California, Forenede Stater, 91361
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68144
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15241
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • 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

12 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.
  • Oral temperature measurement from 100 to 104 degrees Fahrenheit.
  • Onset of fever 3 days or less.
  • Otherwise good health.

Exclusion Criteria:

  • Fever secondary to a chronic underlying medical condition or serious infection.
  • Currently taking antibiotics or antivirals.
  • Currently taking any medication which may interfere with the assessment of fever.
  • Pregnancy or breast-feeding.
  • Any serious medical or psychiatric disorder.

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: EN
Medicin: Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
Placebo komparator: B
Medicin: Placebo
Single dose of a placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
Tidsramme: 0 to 6 hours
STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
0 to 6 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
Tidsramme: 0 to 4, 0 to 8 hours
STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
0 to 4, 0 to 8 hours
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Tidsramme: Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
Time to Treatment Failure
Tidsramme: 0 to 8 hours
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
0 to 8 hours
Cumulative Percentage of Participants With Treatment Failure
Tidsramme: 0.25, 0.5, 1, 2, 4, 6, 8 hours
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
0.25, 0.5, 1, 2, 4, 6, 8 hours
Global Assessment of Study Medication as an Antipyretic
Tidsramme: 8 hours
Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
8 hours
Rating of Study Medication Relative to Usual Medication
Tidsramme: 8 hours
Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
8 hours

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.

Generelle publikationer

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. januar 2010

Primær færdiggørelse (Faktiske)

1. maj 2011

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

8. december 2009

Først indsendt, der opfyldte QC-kriterier

17. december 2009

Først opslået (Skøn)

18. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AH-09-12

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 .

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