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The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

20. november 2013 oppdatert av: Janssen Korea, Ltd., Korea

The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study

The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Studietype

Observasjonsmessig

Registrering (Faktiske)

410

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Korea, Republikken
      • Andong, Korea, Republikken
      • Busan, Korea, Republikken
      • Daegu, Korea, Republikken
      • Daejeon, Korea, Republikken
      • Goyang, Korea, Republikken
      • Incheon, Korea, Republikken
      • Jeonju-Si, Korea, Republikken
      • Kwangiu, Korea, Republikken
      • Kwanju, Korea, Republikken
      • Seoul, Korea, Republikken
      • Wonju-Si, Korea, Republikken

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

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.

Beskrivelse

Inclusion Criteria:

  • Complain of chronic non-cancer pain that persists for >= 3 months
  • Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
  • Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
  • Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
  • A written informed consent for study participation

Exclusion Criteria:

  • Experience of treatment with Fentanyl matrix within the past 4 weeks
  • No previous experience of use of narcotic analgesics
  • Past or current history of alcohol or drug abuse
  • Cannot use transdermal analgesics due to skin disorder
  • Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Fentanylmatrise
Legemiddel: Fentanyl matrix
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
Tidsramme: 12 weeks
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The change from baseline in mean pain intensity
Tidsramme: Baseline, Week 12
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Baseline, Week 12
The difference between the patient's pain treatment goal set at baseline
Tidsramme: Baseline, Week 12
The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Baseline, Week 12
The degree of night sleep disturbance due to pain
Tidsramme: 12 weeks
Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.
12 weeks
The degree of Interference with Daily Life Performance due to Pain
Tidsramme: 12 weeks
The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc.
12 weeks
The degree of Interference with Social Life Performance due to Pain
Tidsramme: 12 weeks
The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc.
12 weeks
The patient's global assessment of pain treatment
Tidsramme: 12 weeks
The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant.
12 weeks
The investigator's global assessment of pain treatment
Tidsramme: 12 weeks
The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.
12 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Janssen Korea, Ltd., Korea

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. desember 2011

Primær fullføring (Faktiske)

1. mars 2013

Studiet fullført (Faktiske)

1. mars 2013

Datoer for studieregistrering

Først innsendt

17. september 2012

Først innsendt som oppfylte QC-kriteriene

17. september 2012

Først lagt ut (Anslag)

20. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2013

Sist bekreftet

1. november 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR100728
  • FENPAI4094 (Annen identifikator: Janssen Korea, Ltd., Korea)
  • FEN-KOR-5045 (Annen identifikator: Janssen Korea, Ltd., Korea)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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