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A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

30. marts 2007 opdateret af: Vernalis (R&D) Ltd

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.

Undersøgelsestype

Interventionel

Tilmelding

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Thornhill, Ontario, Canada, L4J 8L7
        • LMC Endocrinology Centres Ltd.
  • Forenede Stater
    • California
      • Walnut Creek, California, Forenede Stater, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Clinical Research of West Florida, Inc.
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Translational Pain Research Group, Brigham & Women's Hospital
    • Michigan
      • Southfield, Michigan, Forenede Stater, 48034
        • American Center for Clinical Trials
    • Texas
      • San Antonio, Texas, Forenede Stater, 78299-4801
        • Diabetes & Glandular Disease Research Associates Inc.

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:

  • Males or females 18-75 years of age
  • Diabetes mellitus (type I or type II)
  • No change in medications for reducing blood sugar within 4 weeks before screening
  • Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
  • Neuropathic pain must begin in the feet, with relatively symmetrical onset.
  • Willing to perform self-monitoring of blood glucose
  • Able to communicate intelligibly with the investigator and study coordinator
  • Keeping all appointments for clinic visits, tests, and procedures

Exclusion Criteria:

  • Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
  • Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
  • Prior renal transplant or current renal dialysis
  • Pernicious anemia
  • Untreated hypothyroidism
  • Amputations due to diabetes mellitus (with the exception of toes)
  • Any clinically significant abnormal electrocardiogram (ECG)
  • Any history of cardiac arrhythmia
  • History of myocardial infarction
  • Active angina
  • Uncontrolled hypertension (i.e., > 140/90 mm Hg)
  • Known or at high risk of hepatitis B or C infection
  • Known or at high risk of human immunodeficiency virus (HIV) infection
  • Any anticipated need for surgery during the study
  • Glycosylated hemoglobin (HbA1c) > 9%
  • Known seizure disorder
  • Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
  • Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
  • Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine
  • Frequent and/or severe allergic reactions with multiple medications
  • Participation in any clinical trial within 30 days before screening

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: Crossover opgave
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
11 point numerical pain rating scale (NPRS) daily diary

Sekundære resultatmål

Resultatmål
Patients globale indtryk af forandring
Klinisk globalt indtryk af forandring
Neuropatisk smertesymptomoversigt
Modified Brief Pain Inventory for DPN
McGill Pain Questionnaire - Short Form
Medical Outcomes Survey Short Form - 12, Version 2
Patient Preference Questionnaire (end of 2nd treatment period only)
Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
daily sleep interference score

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vernalis (R&D) Ltd

Samarbejdspartnere

Cita NeuroPharmaceuticals

Efterforskere

  • Ledende efterforsker: Christine Sang, M.D., MPH, Brigham and Women's Hospital, Harvard Medical School

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. juni 2006

Studieafslutning

1. april 2007

Datoer for studieregistrering

Først indsendt

11. september 2006

Først indsendt, der opfyldte QC-kriterier

11. september 2006

Først opslået (Skøn)

13. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. april 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2007

Sidst verificeret

1. marts 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V3381-2DPNP01

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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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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