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Actual Use Trial of Naproxen Sodium (Kiefer AUT)

24. september 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

778

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

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

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

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: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm 1
Legemiddel: Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Bayer

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. september 2011

Primær fullføring (Faktiske)

1. desember 2011

Studiet fullført (Faktiske)

1. desember 2011

Datoer for studieregistrering

Først innsendt

31. august 2011

Først innsendt som oppfylte QC-kriteriene

1. september 2011

Først lagt ut (Anslag)

2. september 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2015

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15647

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