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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

369

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Capsaicin 8%
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
Läkemedel: Capsaicin 8%
Capsaicin 8% transdermal delivery system
Andra namn:
  • Qutenza
Placebo-jämförare: Placebo
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
Läkemedel: Placebo
Placebo Patch

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Astellas Pharma Inc

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2012

Primärt slutförande (Faktisk)

1 februari 2014

Avslutad studie (Faktisk)

1 februari 2014

Studieregistreringsdatum

Först inskickad

12 februari 2012

Först inskickad som uppfyllde QC-kriterierna

14 februari 2012

Första postat (Uppskatta)

15 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 oktober 2015

Senast verifierad

1 oktober 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • E05-CL-3004

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