The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement
20 november 2013 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
410
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Andong, Korea, Republiken av
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Busan, Korea, Republiken av
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Daegu, Korea, Republiken av
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Daejeon, Korea, Republiken av
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Goyang, Korea, Republiken av
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Incheon, Korea, Republiken av
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Jeonju-Si, Korea, Republiken av
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Kwangiu, Korea, Republiken av
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Kwanju, Korea, Republiken av
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Seoul, Korea, Republiken av
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Wonju-Si, Korea, Republiken av
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Fentanylmatris
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Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
Tidsram: 12 weeks
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Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
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12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The change from baseline in mean pain intensity
Tidsram: Baseline, Week 12
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Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
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Baseline, Week 12
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The difference between the patient's pain treatment goal set at baseline
Tidsram: Baseline, Week 12
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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).
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Baseline, Week 12
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The degree of night sleep disturbance due to pain
Tidsram: 12 weeks
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Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.
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12 weeks
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The degree of Interference with Daily Life Performance due to Pain
Tidsram: 12 weeks
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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.
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12 weeks
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The degree of Interference with Social Life Performance due to Pain
Tidsram: 12 weeks
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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.
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12 weeks
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The patient's global assessment of pain treatment
Tidsram: 12 weeks
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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.
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12 weeks
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The investigator's global assessment of pain treatment
Tidsram: 12 weeks
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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.
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12 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2011
Primärt slutförande (Faktisk)
1 mars 2013
Avslutad studie (Faktisk)
1 mars 2013
Studieregistreringsdatum
Först inskickad
17 september 2012
Först inskickad som uppfyllde QC-kriterierna
17 september 2012
Första postat (Uppskatta)
20 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 november 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 november 2013
Senast verifierad
1 november 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Kronisk smärta
- Läkemedels fysiologiska effekter
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel, intravenöst
- Anestesimedel, general
- Bedövningsmedel
- Analgetika, Opioid
- Narkotika
- Adjuvans, anestesi
- Fentanyl
Andra studie-ID-nummer
- CR100728
- FENPAI4094 (Annan identifierare: Janssen Korea, Ltd., Korea)
- FEN-KOR-5045 (Annan identifierare: Janssen Korea, Ltd., Korea)
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