- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00044408
Behandling af symptomatisk perifer neuropati hos patienter med diabetes
25. juli 2016 opdateret af: Chromaderm, Inc.
LY333531 Behandling af symptomatisk perifer neuropati hos patienter med diabetes
Formålet med denne protokol er at bestemme, om et forsøgslægemiddel kendt som LY333531 er effektivt til behandling af nervefejl ved diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
200
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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British Columbia
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Vancouver, British Columbia, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manitoba
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Winnipeg, Manitoba, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nova Scotia
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Halifax, Nova Scotia, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ontario
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Toronto, Ontario, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Quebec
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Laval, Quebec, Canada
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester, Det Forenede Kongerige
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Dorset
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Poole, Dorset, Det Forenede Kongerige
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Manchester
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Salford, Manchester, Det Forenede Kongerige
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Shropshire
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Shrewsbury, Shropshire, Det Forenede Kongerige
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Yorkshire
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Sheffield, South Yorkshire, Det Forenede Kongerige
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Helsinki, Finland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jyvaskyla, Finland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oulu, Finland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Long Beach, California, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Connecticut
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Norwalk, Connecticut, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Clearwater, Florida, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plantation, Florida, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Idaho Falls, Idaho, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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North Chicago, Illinois, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Baltimore, Maryland, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Boston, Massachusetts, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Columbia, Missouri, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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New York, New York, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Columbia, South Carolina, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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San Antonio, Texas, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Amersfoort, Holland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyderabad, Indien
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Chennai
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Gopalapuram, Chennai, Indien
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Maharashtra
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Mumbai, Maharashtra, Indien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zagreb, Kroatien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaunas, Litauen
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Klaipeda, Litauen
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vilnus, Litauen
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Patienter skal have type I eller type II diabetes mellitus.
- Har klinisk diagnosticeret positive sensoriske symptomer såsom følelsesløshed, snerpende smerter, brændende smerter, ømme smerter, allodyni og prikkende fornemmelse, der ikke har været til stede i mere end 5 år, men stabile i 6 måneder.
- Har et HbA1C mindre end eller lig med 12%. Patienter med HbA1C større end 9 % skal være i insulinbehandling.
- Skal være 18 år eller ældre.
- Vær i stand til at besøge lægekontoret cirka 3 gange over en periode på højst 6 uger for at afgøre, om du kan fortsætte i undersøgelsen.
Ekskluderingskriterier:
- Historie om betydelige leverproblemer.
- Har dårlig nyrefunktion.
- Drik et overskud af alkohol eller misbrug stoffer.
- Har for nylig deltaget eller deltager i en medicinsk undersøgelse, hvor du modtager et eksperimentelt lægemiddel.
- Er en kvinde og er gravid eller ammer, har til hensigt at blive gravid inden for de næste 2 år eller en kvinde, der ikke bruger effektiv prævention.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Reduktion af neuropatiske symptomer
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Sekundære resultatmål
Resultatmål |
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Vibrationsfornemmelse; Neurologiske tegn; Elektrofysiologi af peroneale, tibiale og surale nerver; Lindring af symptomer målt ved VAS; Sammensatte scorer af nervefunktion; Klinisk globalt indtryk af forandring
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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 2002
Studieafslutning (Faktiske)
1. oktober 2005
Datoer for studieregistrering
Først indsendt
28. august 2002
Først indsendt, der opfyldte QC-kriterier
29. august 2002
Først opslået (Skøn)
30. august 2002
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Sygdomme i det endokrine system
- Diabetes komplikationer
- Neuromuskulære sygdomme
- Diabetes mellitus
- Diabetes mellitus, type 2
- Diabetes mellitus, type 1
- Sygdomme i det perifere nervesystem
- Diabetiske neuropatier
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Ruboxistaurin
Andre undersøgelses-id-numre
- 6204
- B7A-MC-MBCW
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 Diabetiske neuropatier
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Assiut UniversityUkendtom Vitreomacular Interface Abnormalities in Diabetic Retinopathy
Kliniske forsøg med Ruboxistaurinmesylat
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Chromaderm, Inc.AfsluttetDiabetisk retinopatiForenede Stater
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Chromaderm, Inc.AfsluttetDiabetisk retinopatiForenede Stater, Canada, Frankrig, Danmark, Australien, Holland, Taiwan, Spanien, Italien, Tyskland, Portugal, Det Forenede Kongerige, Den Russiske Føderation, Polen, Indien, Brasilien, Mexico
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Chromaderm, Inc.Afsluttet
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Chromaderm, Inc.Heart and Stroke Foundation of CanadaAfsluttetDiabetes mellitus, type 1Canada
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Chromaderm, Inc.AfsluttetDiabetisk nefropatiForenede Stater
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Eli Lilly and CompanyAfsluttetDiabetes mellitus | Diabetiske neuropatierForenede Stater, Spanien, Australien, Belgien, Canada, Kroatien, Danmark, Estland, Finland, Tyskland, Ungarn, Indien, Litauen, Holland, Det Forenede Kongerige
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Eli Lilly and CompanyAfsluttetDiabetiske neuropatier | Diabetes mellitus, ikke-insulinafhængig | Diabetes mellitus, insulinafhængigForenede Stater, Spanien, Ungarn, Australien, Belgien, Danmark, Estland, Tyskland, Israel
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University of TennesseeThe Christ HospitalTrukket tilbage
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Chromaderm, Inc.Afsluttet
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Chromaderm, Inc.AfsluttetDiabetisk makulært ødemForenede Stater, Danmark, Mexico, Tyskland, Spanien, Canada, Litauen, Portugal, Rumænien, Det Forenede Kongerige