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Actual Use Trial of Naproxen Sodium (Kiefer AUT)

24. september 2015 opdateret af: Bayer

An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

778

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
      • Hoover, Alabama, Forenede Stater, 35226
      • McCalla, Alabama, Forenede Stater, 35111-3406
      • Pinson, Alabama, Forenede Stater, 35126
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85202
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Oceanside, California, Forenede Stater, 92054
      • Yorba Linda, California, Forenede Stater, 92886
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66209
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21228
    • Minnesota
      • Andover, Minnesota, Forenede Stater, 55304
      • Elk River, Minnesota, Forenede Stater, 55330
      • Fridley, Minnesota, Forenede Stater, 55432
      • Northfield, Minnesota, Forenede Stater, 55057-2434
      • Rosemount, Minnesota, Forenede Stater, 55068
      • Roseville, Minnesota, Forenede Stater, 55113
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
      • Savannah, Missouri, Forenede Stater, 64485
      • St. Joseph, Missouri, Forenede Stater, 64504
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87104
      • Albuquerque, New Mexico, Forenede Stater, 87107
      • Taos, New Mexico, Forenede Stater, 87571
    • Utah
      • Bountiful, Utah, Forenede Stater, 84010
      • Hurricane, Utah, Forenede Stater, 84737
      • Layton, Utah, Forenede Stater, 84041
      • Ogden, Utah, Forenede Stater, 84401
      • Salt Lake City, Utah, Forenede Stater, 84121
      • Salt Lake City, Utah, Forenede Stater, 84102
      • Syracuse, Utah, Forenede Stater, 84075
      • West Jordan, Utah, Forenede Stater, 84088
    • Virginia
      • Montpelier, Virginia, Forenede Stater, 23192
      • Richmond, Virginia, Forenede Stater, 23221
    • Washington
      • Bellevue, Washington, Forenede Stater, 98007
      • Kenmore, Washington, Forenede Stater, 98028
      • Snohomish, Washington, Forenede Stater, 98290

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 og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • At least 12 years of age
  • Report taking OTC analgesics for pain on at least 5 days in the last month
  • Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
  • Able to read and understand English
  • Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
  • Provide contact information
  • Purchase the investigational product

Exclusion Criteria:

  • Have participated in a trial involving OTC analgesics in the last 6 months
  • They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
  • Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)
  • Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
  • (Female subjects) are pregnant or breastfeeding

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Medicin: Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Percentage of Misuse for Non-Therapeutic Reasons
Tidsramme: 28 days
The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.
28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-therapeutic Reasons for Misuse
Tidsramme: 28 days
Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.
28 days
Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
Tidsramme: 28 days
This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."
28 days
Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
Tidsramme: 28 days
Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
28 days
Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
Tidsramme: 28 days
Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.
28 days
Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
Tidsramme: 28 days
Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
28 days
Percentage of Dosing Occasions Where More Than One Tablet Was Taken
Tidsramme: 28 days
Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
28 days
Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Tidsramme: 28 days
Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.
28 days
Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Tidsramme: 28 days
Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection
28 days

Samarbejdspartnere og efterforskere

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

Sponsor

Bayer

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. september 2011

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

31. august 2011

Først indsendt, der opfyldte QC-kriterier

1. september 2011

Først opslået (Skøn)

2. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2015

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15647

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 Naproxen Sodium ER (BAYH6689)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Egypt

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner