- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00044421
Treatment of Peripheral Neuropathy in Patients With Diabetes
5. november 2007 opdateret af: Eli Lilly and Company
LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
400
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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New South Wales
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Camperdown, New South Wales, Australien
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St. Leonards, New South Wales, Australien
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Victoria
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Caulfield, Victoria, Australien
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Clayton, Victoria, Australien
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Edegem, Belgien
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Huy, Belgien
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Willebroeck, Belgien
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British Columbia
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Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Toronto, Ontario, Canada
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
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Quebec
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Laval, Quebec, Canada
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Aarhus C, Danmark
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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
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South Yorkshire
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Sheffield, South Yorkshire, Det Forenede Kongerige
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Keila, Estland
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Tallinn, Estland
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Helsinki, Finland
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Jyvaskyla, Finland
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Oulu, Finland
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Arizona
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Mesa, Arizona, Forenede Stater
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California
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Irvine, California, Forenede Stater
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Long Beach, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Tustin, California, Forenede Stater
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Connecticut
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New Britain, Connecticut, Forenede Stater
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Norwalk, Connecticut, Forenede Stater
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Florida
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Clearwater, Florida, Forenede Stater
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Plantation, Florida, Forenede Stater
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Weston, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Idaho
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Idaho Falls, Idaho, Forenede Stater
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Illinois
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North Chicago, Illinois, Forenede Stater
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Indiana
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Indianapolis, Indiana, Forenede Stater
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Maryland
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Baltimore, Maryland, Forenede Stater
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Massachusetts
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Boston, Massachusetts, Forenede Stater
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
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Missouri
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Columbia, Missouri, Forenede Stater
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Nebraska
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Omaha, Nebraska, Forenede Stater
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Nevada
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Henderson, Nevada, Forenede Stater
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New Jersey
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Medford, New Jersey, Forenede Stater
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New York
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Buffalo, New York, Forenede Stater
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New York, New York, Forenede Stater
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South Carolina
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Columbia, South Carolina, Forenede Stater
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Texas
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Dallas, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater
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Vermont
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Burlington, Vermont, Forenede Stater
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Virginia
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Norfolk, Virginia, Forenede Stater
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West Virginia
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Morgantown, West Virginia, Forenede Stater
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Amersfoort, Holland
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Chennai
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Gopalapuram, Chennai, Indien
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Karnataka
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Bangalore, Karnataka, Indien
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Maharashtra
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Mumbai, Maharashtra, Indien
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Tamil Nadu
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Chennai, Tamil Nadu, Indien
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Zagreb, Kroatien
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Kaunas, Litauen
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Klaipeda, Litauen
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Vilnus, Litauen
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Madrid, Spanien
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La Coruna
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Santiago, La Coruna, Spanien
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Sevilla
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Dos Hermanas, Sevilla, Spanien
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Dresden, Tyskland
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Dusseldorf, Tyskland
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Mainz, Tyskland
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Budapest, Ungarn
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Debrecen, Ungarn
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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
Inclusion Criteria:
- Patients must have type I or type II Diabetes Mellitus.
- Have been clinically diagnosed with neuropathy.
- Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
- Must be 18 years or older.
- Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
Exclusion Criteria:
- History of significant liver problems.
- Have poor kidney function.
- Drink an excess of alcohol or abuse drugs.
- Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
- Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
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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Reduction in the progression of DPN measured by composite score
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Sekundære resultatmål
Resultatmål |
|---|
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Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1977-285-4559) or 1317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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 2006
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)
6. november 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2007
Sidst verificeret
1. november 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Sygdomme i det endokrine system
- Diabetes komplikationer
- Neuromuskulære sygdomme
- Diabetes mellitus
- Sygdomme i det perifere nervesystem
- Diabetiske neuropatier
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Ruboxistaurin
Andre undersøgelses-id-numre
- 2784
- B7A-MC-MBBR
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 .