- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00126763
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
4. juni 2012 opdateret af: ZARS Pharma Inc.
An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Non-Malignant Chronic Pain
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of non-malignant chronic pain.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will evaluate the safety of the matrix fentanyl patch.
The study will be conducted in opioid-tolerant patients with moderate to severe non-malignant chronic pain currently taking an around-the-clock opioid.
Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study.
Patient's dose of ZR 02 01 will be determined by the investigator using sponsor-provided conversion.
Pain therapy will be under the supervision of the physician investigator.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85023
- Arizona Reserach Center
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California
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda Center for Pain Management
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Drug Studies America
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Kansas
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Overland Park, Kansas, Forenede Stater, 66211
- Pain Management Institute
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Missouri
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Kansas City, Missouri, Forenede Stater, 64137
- Pain Management Associates
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27103
- The Center for Clinical Research
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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:
- Patient is at least 18 and no older than 75 years of age
- Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
- Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.
Exclusion Criteria:
- Patient has active cancer
- Patient has a history of substance abuse or has a substance abuse disorder
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 |
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Eksperimentel: Matrix Transdermal Fentanyl Patch
|
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches.
For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose.
For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines.
The patches were worn on the chest or upper arm and an overlay was placed over the patch.
Patches (and overlays) were replaced every 3 days
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants with adverse eventsTo
Tidsramme: 12 months
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Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain
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12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain Intensity
Tidsramme: 12 months
|
Patient will rate pain intensity using a 100 mm VAS in which "0" equals "No Pain" and "100" equals "The Worst Pain You Can Imagine."
Patients will be instructed on how to use the VAS and will base their response on the average pain that they experienced over the previous 24 hours.
VAS will be collected at all study visits except screening.
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Richard Rauck, MD, The Center for Clinical Research
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. juli 2005
Primær færdiggørelse (Faktiske)
1. december 2006
Studieafslutning (Faktiske)
1. december 2006
Datoer for studieregistrering
Først indsendt
2. august 2005
Først indsendt, der opfyldte QC-kriterier
2. august 2005
Først opslået (Skøn)
4. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2012
Sidst verificeret
1. juni 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Kronisk smerte
- 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
- ZMF-303
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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-
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Kliniske forsøg med Fentanyl Transdermal Matrix Patch ZR-02-01
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ZARS Pharma Inc.Afsluttet
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ZARS Pharma Inc.AfsluttetSmerte | KræftForenede Stater
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ZARS Pharma Inc.Afsluttet
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ZARS Pharma Inc.AfsluttetSlidgigtForenede Stater
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Washington University School of MedicineRekrutteringGraviditetskomplikationer | Graviditetsrelateret | Graviditet, høj risiko | Opioidbrugsforstyrrelse | Buprenorphin abstinenserForenede Stater