Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)

19. januar 2017 opdateret af: Mundipharma Korea Ltd

An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY)

Objectives:

  1. Objective of main interest

    - To assess the drop-out rate caused by adverse event* after 6 weeks treatment

  2. Further objectives

    • To assess the drop-out rate caused by adverse event* after 1 week treatment
    • To assess the pain reduction rate after 6 weeks treatment from baseline
    • To assess the Euroquol (EQ-5D) quality of life
    • To assess physician's overall satisfaction
    • To assess subject's overall satisfaction
    • To assess safety

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Design (Methodology):

This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

261

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female ≥ 20 and <80 years of age
  • Patients who have non-malignant chronic pain(≥90 days)
  • Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
  • Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
  • Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
  • Patients who signed a written informed consent form

Exclusion Criteria:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
  • Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
  • Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
  • Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group A
Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Medicin: Oxycodone/naloxone
Oxycodone/naloxone titration
Andre navne:
  • Targin
Andet: Group B
Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Medicin: Oxycodone/naloxone
Oxycodone/naloxone titration
Andre navne:
  • Targin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
Tidsramme: 6 weeks
To assess the drop-out rate caused by adverse event* after 6 weeks treatment
6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
Tidsramme: 1 week
The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.
1 week
The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
Tidsramme: 6 weeks
Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable).
6 weeks
Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
Tidsramme: 6 weeks

EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).

Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)

*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)

EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.
6 weeks
Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Tidsramme: 6 weeks
Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.
6 weeks
Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Tidsramme: 6weeks
At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).
6weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Mundipharma Korea Ltd

Efterforskere

  • Ledende efterforsker: Hoseong Lee, Dr., Asan Medical Center

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. december 2012

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

12. marts 2013

Først indsendt, der opfyldte QC-kriterier

12. marts 2013

Først opslået (Skøn)

14. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OXN12-KR-403

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Kronisk smerte

Kliniske forsøg med Oxycodone/naloxone

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Belgium

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner