A Study to Evaluate the Efficacy and Safety of a Single Application of QUTENZA Compared to That of Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) (STEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01533428
First received: February 12, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to assess how well a single treatment of QUTENZA reduces pain from damaged nerves (neuropathic pain) caused by diabetes and how safe QUTENZA is when compared to using a placebo.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Pain
Drug: QUTENZA
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Percent change in the average daily pain score through week 8 [ Time Frame: Baseline & week 8 ] [ Designated as safety issue: No ]
    Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) from the average assessed during the baseline run-in period to the average daily pain score assessed between weeks 2 and 8.


Secondary Outcome Measures:
  • Percent change in the average daily pain score through week 12 [ Time Frame: Baseline & week 12 ] [ Designated as safety issue: No ]
    Question 5 of the BPI-DN from the average assessed during the baseline run-in period to the average daily pain score assessed between weeks 2 and 12 (i.e., average of scores during weeks 2 to 12, compared to the average of baseline scores).

  • Percent change of weekly average of "Average pain for the past 24 hours" [ Time Frame: Baseline, week 2, week 4, week 8 & week 12 ] [ Designated as safety issue: No ]
    Numeric Pain Rating Scale (NPRS) scores from baseline at every week after baseline.

  • Weekly average of "Average pain for the past 24 hours" [ Time Frame: Baseline, week 2, week 4, week 8 & week 12 ] [ Designated as safety issue: No ]
    NPRS scores at baseline and every week after baseline. Assessed within 15 minutes and 60 minutes after removal of the patch.

  • Proportion of subjects achieving 30% and 50% decrease in the average daily Pain score [ Time Frame: Baseline, week 8 & week 12 ] [ Designated as safety issue: No ]
    Question 5 of the BPI-DN from the average assessed during baseline run in period to the average daily pain score assessed between weeks 2 and 8 and weeks 2 and 12.

  • Overall patient status using Patient Global Impression of Change (PGIC) questionnaire at weeks 2, 8 and 12 [ Time Frame: Week 2, week 8 & week 12 ] [ Designated as safety issue: No ]
  • Change in the European QOL questionnaire in 5 dimensions (EQ-5D) total score and Depression and Anxiety scores on the Hospital Anxiety and Depression Scale (HADS) from baseline to weeks 8 and 12 [ Time Frame: Week 8 & week 12 ] [ Designated as safety issue: No ]
  • Treatment satisfaction using the Self-Assessment of Treatment (SAT II) questionnaire at baseline, weeks 8 and 12 [ Time Frame: Baseline, week 8 & week 12 ] [ Designated as safety issue: No ]
  • Percent change in the sleep interference NPRS score [ Time Frame: Baseline, week 8 & week 12 ] [ Designated as safety issue: No ]
    Question 9F of the BPI DN from baseline to week 2-8 and week 2-12 (i.e., average of scores during weeks 2 to 8 and 2-12, compared to baseline).

  • Tolerability of patch application assessed by dermal assessment [ Time Frame: Week 1 & Week 12 ] [ Designated as safety issue: No ]
    0-7 point severity score on Dermal Assessment Scale

  • "Pain now" NPRS scores before and after patch application [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Tolerability of patch application assessed by rescue pain medication use on days 1 through 5 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Safety assessed through Adverse Events, vital signs, and laboratory analyses [ Time Frame: Week 2, week 4, week 8 & week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 369
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Qutenza
QUTENZA patch will be applied for 30 minutes to the painful area(s)
Drug: QUTENZA
Qutenza (8% capsaicin) patch
Other Name: Capsaisin
Placebo Comparator: 2. Placebo
Placebo patch will be applied for 30 minutes to the painful area(s)
Drug: Placebo
Placebo Patch

Detailed Description:

Patients will be divided into 2 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a placebo patch applied for 30 minutes to the feet. Subjects will be involved in the study for up to approximately 12 weeks and will have to visit the clinic approximately 6 times.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary pain associated with PDPN in the ankles or above
  • Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN, 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 QUTENZA 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 QUTENZA showing changes such as crusting or ulcers
  • Planned elective surgery during the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533428

  Show 29 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01533428     History of Changes
Other Study ID Numbers: E05-CL-3004
Study First Received: February 12, 2012
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Painful Diabetic Peripheral Neuropathy,
Qutenza

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014