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A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) (STEP)

12 oktober 2015 bijgewerkt door: Astellas Pharma Inc

A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy

The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

369

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Anniston, Alabama, Verenigde Staten, 36207
        • Site: 125
    • California
      • Fresno, California, Verenigde Staten, 93720
        • Site: 131
      • Long Beach, California, Verenigde Staten, 90806
        • Site: 123
      • Los Angeles, California, Verenigde Staten, 90033
        • Site: 116
      • Orange, California, Verenigde Staten, 92868
        • Site: 112
      • Walnut Creek, California, Verenigde Staten, 94597
        • Site: 130
    • Connecticut
      • Milford, Connecticut, Verenigde Staten, 06460
        • Site: 113
      • New London, Connecticut, Verenigde Staten, 06320
        • Site: 119
    • Florida
      • Boynton Beach, Florida, Verenigde Staten, 33435
        • Site: 117
      • Bradenton, Florida, Verenigde Staten, 34205
        • Site: 124
      • Clearwater, Florida, Verenigde Staten, 33765
        • Site: 107
      • Jupiter, Florida, Verenigde Staten, 33458
        • Site: 120
      • Orlando, Florida, Verenigde Staten, 32806
        • Site: 108
      • Oviedo, Florida, Verenigde Staten, 32765
        • Site: 132
      • St. Petersburg, Florida, Verenigde Staten, 33709
        • Site: 127
      • Tampa, Florida, Verenigde Staten, 33606
        • Site: 122
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96814
        • Site: 133
    • Massachusetts
      • New Bedford, Massachusetts, Verenigde Staten, 02740
        • Site: 126
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48104
        • Site: 115
    • Missouri
      • Hazelwood, Missouri, Verenigde Staten, 63042
        • Site: 128
    • New York
      • New York, New York, Verenigde Staten, 10029
        • Site:111
    • North Carolina
      • Winston-Salem, North Carolina, Verenigde Staten, 27103
        • Site: 110
    • Ohio
      • Kettering, Ohio, Verenigde Staten, 45429
        • Site: 121
    • Texas
      • Dallas, Texas, Verenigde Staten, 75230
        • Site:106
      • Houston, Texas, Verenigde Staten, 77030
        • Site: 118
      • Houston, Texas, Verenigde Staten, 77098
        • Site: 114
      • Lubbock, Texas, Verenigde Staten, 79410
        • Site: 103
      • San Antonio, Texas, Verenigde Staten, 78228
        • Site: 105
      • San Antonio, Texas, Verenigde Staten, 78229
        • Site: 102

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to screening visit
  • Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of ≥4 at the screening and the baseline visit

Exclusion Criteria:

  • Primary pain associated with PDPN (Painful Diabetic Peripheral Neuropathy) in the ankles or above
  • Pain that could not be clearly differentiated from, or conditions that might interfere with the assessment of PDPN (Painful Diabetic Peripheral Neuropathy), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer)
  • Current or previous foot ulcer as determined by medical history and medical examination
  • Any amputation of lower extremity
  • Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated according to the Cockcroft-Gault formula
  • Clinically significant cardiovascular disease within 6 months prior to screening visit defined as cerebrovascular accident, unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia, any heart surgery including coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease
  • Significant peripheral vascular disease (intermittent claudication or lack of pulsation of either the dorsalis pedis or posterior tibial artery, or ankle-brachial systolic blood pressure index of <0.80)
  • Clinically significant foot deformities, including hallux rigidus, hallux valgus, or rigid toe as determined by physical examination as judged by the investigator
  • Clinically significant ongoing, uncontrolled or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
  • Diagnosis of any poorly controlled major psychiatric disorder
  • Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
  • Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any Capsaicin 8% transdermal delivery system excipients, Eutectic Mixture of Local Anaesthetics (EMLA) ingredients or adhesives
  • Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application at the baseline visit
  • Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application at the baseline visit
  • Skin areas to be treated with Capsaicin 8% transdermal delivery system showing changes such as crusting or ulcers
  • Planned elective surgery during the trial

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Capsaicin 8%
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
Geneesmiddel: Capsaicin 8%
Capsaicin 8% transdermal delivery system
Andere namen:
  • Qutenza
Placebo-vergelijker: Placebo
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
Geneesmiddel: Placebo
Placebo Patch

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Tijdsspanne: Baseline to between Weeks 2 to 8
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline to between Weeks 2 to 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Tijdsspanne: Baseline to between Weeks 2 and 12
Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline to between Weeks 2 and 12
Weekly Percent Change From Baseline in Average Daily Pain Score
Tijdsspanne: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Tijdsspanne: Baseline and Weeks 2, 4, 8 and 12
Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With 30% Reduction in Average Daily Pain Score.
Tijdsspanne: Baseline, Weeks 2-8 and Weeks 2-12
Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline, Weeks 2-8 and Weeks 2-12
Percentage of Participants With 50% Reduction in Average Daily Pain Score.
Tijdsspanne: Baseline, Weeks 2-8 and Weeks 2-12
Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline, Weeks 2-8 and Weeks 2-12
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Tijdsspanne: Baseline to Week 2
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2
Baseline to Week 2
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Tijdsspanne: Baseline to Week 8
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8
Baseline to Week 8
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Tijdsspanne: Baseline to Week 12
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12
Baseline to Week 12
Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12
Tijdsspanne: Baseline to Weeks 2, 8 and 12
Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).
Baseline to Weeks 2, 8 and 12
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
Tijdsspanne: Baseline to Weeks 2, 8 and 12
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
Baseline to Weeks 2, 8 and 12
Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
Tijdsspanne: Baseline to Weeks 2, 8 and 12
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
Baseline to Weeks 2, 8 and 12
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Tijdsspanne: Baseline, Weeks 8 and 12
Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question "Over the past 7 days, how much has the study treatment improved your pain level?"
Baseline, Weeks 8 and 12
Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12
Tijdsspanne: Baseline, Weeks 2-8 and Weeks 2-12
Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies "pain does not interfere with sleep" and 10 identifies "pain completely interferes with sleep". Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12.
Baseline, Weeks 2-8 and Weeks 2-12
Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.
Tijdsspanne: Day 1, 15 minutes and 60 minutes after patch removal
Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.
Day 1, 15 minutes and 60 minutes after patch removal
Change From Pre-application in"Pain Now" Score
Tijdsspanne: Pre-application and 15 minutes and 60 minutes after patch removal
Change from pre-application in"Pain Now" score was measured on a scale from 0-10 where 0 equates to "No Pain" and 10 to "Pain as bad as you can imagine". Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment.
Pre-application and 15 minutes and 60 minutes after patch removal
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Tijdsspanne: Days 1 - 5
Summarized number of participants who used Rescue Pain Medications for Pain
Days 1 - 5
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Tijdsspanne: Baseline to Week 12
Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12
Baseline to Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Astellas Pharma Inc

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2012

Primaire voltooiing (Werkelijk)

1 februari 2014

Studie voltooiing (Werkelijk)

1 februari 2014

Studieregistratiedata

Eerst ingediend

12 februari 2012

Eerst ingediend dat voldeed aan de QC-criteria

14 februari 2012

Eerst geplaatst (Schatting)

15 februari 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

4 november 2015

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2015

Laatst geverifieerd

1 oktober 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E05-CL-3004

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