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Phase 2 Chronic Low Back Pain Study

23. december 2013 opdateret af: AbbVie (prior sponsor, Abbott)

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

168

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85704
        • Site Reference ID/Investigator# 54875
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Site Reference ID/Investigator# 54876
      • Burbank, California, Forenede Stater, 91505
        • Site Reference ID/Investigator# 54877
      • Lomita, California, Forenede Stater, 90717
        • Site Reference ID/Investigator# 54873
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • Site Reference ID/Investigator# 54874
      • Oldsmar, Florida, Forenede Stater, 34677
        • Site Reference ID/Investigator# 54866
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Site Reference ID/Investigator# 54879
    • Indiana
      • Valparaiso, Indiana, Forenede Stater, 46383
        • Site Reference ID/Investigator# 54865
    • Kansas
      • Prairie Village, Kansas, Forenede Stater, 66206
        • Site Reference ID/Investigator# 54782
    • Maryland
      • Pasadena, Maryland, Forenede Stater, 21122
        • Site Reference ID/Investigator# 54862
    • Massachusetts
      • Watertown, Massachusetts, Forenede Stater, 02472-3930
        • Site Reference ID/Investigator# 54878
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63141
        • Site Reference ID/Investigator# 54880
    • New York
      • Williamsville, New York, Forenede Stater, 14221
        • Site Reference ID/Investigator# 54881
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45227
        • Site Reference ID/Investigator# 54872
      • Marion, Ohio, Forenede Stater, 43302
        • Site Reference ID/Investigator# 54863
    • Texas
      • Killeen, Texas, Forenede Stater, 76543
        • Site Reference ID/Investigator# 54745
      • San Antonio, Texas, Forenede Stater, 78209-1744
        • Site Reference ID/Investigator# 54742

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:

Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

Exclusion Criteria:

Subjects with a history of surgical or invasive intervention

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Open-label Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 2 tablets twice daily
Medicin: hydrocodone/acetaminophen extended release
Andre navne:
  • ABT-712
Eksperimentel: Double-blind Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 1 tablet twice daily
Medicin: hydrocodone/acetaminophen extended release
Andre navne:
  • ABT-712
Placebo komparator: Double-blind Placebo
Placebo, 1 tablet twice daily
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
Tidsramme: Double-blind baseline to Day 29
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
Double-blind baseline to Day 29

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's Global Assessment of Back Pain Status at Final Evaluation
Tidsramme: Double-blind baseline to Day 29
The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Double-blind baseline to Day 29
Participant's Global Assessment of Study Drug at Final Evaluation
Tidsramme: Double-blind baseline to Day 29
The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor.
Double-blind baseline to Day 29

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

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. juni 2011

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

1. juni 2011

Først indsendt, der opfyldte QC-kriterier

1. juni 2011

Først opslået (Skøn)

3. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M12-807

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 Placebo

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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