- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01060137
Fentanyl Matrix in Lung Cancer Pain
4. februar 2010 opdateret af: Janssen Korea, Ltd., Korea
Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain.
Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Studieoversigt
Detaljeret beskrivelse
This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days.
Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation.
Safety assessments will include adverse event monitoring, vital signs, laboratory work.
starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
268
Fase
- Fase 4
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with histologically confirmed lung cancer, who complain of cancer pain
- Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day
- Patients who are able to communicate with the investigator about his/her pain
- Patients who use proper contraceptives during the study period if they are women of childbearing potential
- Patients whose life expectancy is 3 months or longer
- Patients who have signed an informed consent form
Exclusion Criteria:
- Patients participating in other clinical trials
- Patients with a history of hypersensitivity to opioid analgesics
- Patients with a history of drug abuse
- Patients who are unable to use a transdermal product due to skin disease
- Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)
- Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study
- Patient who are pregnant or are of childbearing potential and not using contraceptives
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 001
fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment
|
Fentanyl transdermal patch 12 - 25mcg/hr
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Patient's satisfaction with pain treatment as measured by 5-point verbal scale
Tidsramme: Day 1, 8 and 22
|
Day 1, 8 and 22
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
Tidsramme: Day 1 (visit 1) and 22 (visit 3)
|
Day 1 (visit 1) and 22 (visit 3)
|
Detailed reasons for patient's satisfaction with the pain treatment
Tidsramme: Day 22 (visit 3)
|
Day 22 (visit 3)
|
Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug
Tidsramme: Day 22 (visit 3)
|
Day 22 (visit 3)
|
Dose of fentanyl matrix
Tidsramme: Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)
|
Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. maj 2006
Primær færdiggørelse (Faktiske)
1. maj 2007
Studieafslutning (Faktiske)
1. maj 2007
Datoer for studieregistrering
Først indsendt
29. januar 2010
Først indsendt, der opfyldte QC-kriterier
29. januar 2010
Først opslået (Skøn)
2. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. februar 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2010
Sidst verificeret
1. februar 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Analgetika, Opioid
- Narkotika
- Adjuvanser, anæstesi
- Fentanyl
Andre undersøgelses-id-numre
- CR012259
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 .
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