Treatment of Peripheral Neuropathy in Patients With Diabetes
5. November 2007 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung
400
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New South Wales
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Camperdown, New South Wales, Australien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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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Dresden, Deutschland
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Dusseldorf, Deutschland
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Mainz, Deutschland
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Aarhus C, Dänemark
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Keila, Estland
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Tallinn, Estland
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Helsinki, Finnland
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Jyvaskyla, Finnland
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Oulu, Finnland
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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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British Columbia
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Vancouver, British Columbia, Kanada
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Manitoba
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Winnipeg, Manitoba, Kanada
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Nova Scotia
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Halifax, Nova Scotia, Kanada
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Ontario
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Toronto, Ontario, Kanada
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Prince Edward Island
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Charlottetown, Prince Edward Island, Kanada
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Quebec
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Laval, Quebec, Kanada
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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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Amersfoort, Niederlande
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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
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
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Budapest, Ungarn
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Debrecen, Ungarn
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Arizona
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Mesa, Arizona, Vereinigte Staaten
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California
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Irvine, California, Vereinigte Staaten
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Long Beach, California, Vereinigte Staaten
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Los Angeles, California, Vereinigte Staaten
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Tustin, California, Vereinigte Staaten
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Connecticut
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New Britain, Connecticut, Vereinigte Staaten
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Norwalk, Connecticut, Vereinigte Staaten
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Florida
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Clearwater, Florida, Vereinigte Staaten
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Plantation, Florida, Vereinigte Staaten
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Weston, Florida, Vereinigte Staaten
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Georgia
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Atlanta, Georgia, Vereinigte Staaten
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Idaho
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Idaho Falls, Idaho, Vereinigte Staaten
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Illinois
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North Chicago, Illinois, Vereinigte Staaten
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten
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Maryland
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Baltimore, Maryland, Vereinigte Staaten
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten
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Missouri
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Columbia, Missouri, Vereinigte Staaten
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten
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Nevada
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Henderson, Nevada, Vereinigte Staaten
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New Jersey
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Medford, New Jersey, Vereinigte Staaten
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New York
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Buffalo, New York, Vereinigte Staaten
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New York, New York, Vereinigte Staaten
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South Carolina
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Columbia, South Carolina, Vereinigte Staaten
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Texas
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Dallas, Texas, Vereinigte Staaten
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Houston, Texas, Vereinigte Staaten
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San Antonio, Texas, Vereinigte Staaten
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Vermont
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Burlington, Vermont, Vereinigte Staaten
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Virginia
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Norfolk, Virginia, Vereinigte Staaten
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Morgantown, West Virginia, Vereinigte Staaten
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Manchester, Vereinigtes Königreich
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Dorset
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Poole, Dorset, Vereinigtes Königreich
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Manchester
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Salford, Manchester, Vereinigtes Königreich
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Shropshire
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Shrewsbury, Shropshire, Vereinigtes Königreich
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South Yorkshire
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Sheffield, South Yorkshire, Vereinigtes Königreich
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
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Reduction in the progression of DPN measured by composite score
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
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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
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juli 2002
Studienabschluss (Tatsächlich)
1. Oktober 2006
Studienanmeldedaten
Zuerst eingereicht
28. August 2002
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. August 2002
Zuerst gepostet (Schätzen)
30. August 2002
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
6. November 2007
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. November 2007
Zuletzt verifiziert
1. November 2007
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Erkrankungen des Nervensystems
- Erkrankungen des endokrinen Systems
- Diabetes-Komplikationen
- Neuromuskuläre Erkrankungen
- Diabetes Mellitus
- Erkrankungen des peripheren Nervensystems
- Diabetische Neuropathien
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Ruboxistaurin
Andere Studien-ID-Nummern
- 2784
- B7A-MC-MBBR
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .