NL-OMON39911已完成3 期
A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy - PACE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
- •2. Male or female >18 years of age
- •3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to screening visit
- •4. Diagnosis of PDPN confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument (MNSI)
- •5. At least one medical record of glycosylated hemoglobin (HbA1c) of <9% at 3-6 months before screening visit and an HbA1c of <9% at screening visit. A subject who has an HbA1c of >9% at the screening visit, for whom the pre-screening value was <9%, may undergo a more intensive period of diabetes treatment for 3 months and be re-screened. Upon re-screening, the subject may be enrolled if the HbA1c is <9% or if the investigator attests that Diabetes Mellitus (DM) is appropriately optimized for that subject
- •6. Stable glycemic control for at least 6 months prior to screening visit, i.e., on antidiabetic drugs (including insulin and/or oral hypoglycemic agents [OHA] )
- •7. Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit
排除标准
- •1. Primary pain associated with PDPN in the ankles or above
- •2. Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN, such as plantar fasciitis, heel spurs, tibial neuropathy, Morton*s neuroma, bunions, metatarsalgia, arthritis in feet, peripheral vascular disease (ischemic pain), 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)
- •3. Significant pain (moderate or above) of an etiology other than PDPN (e.g., compression-related neuropathies [e.g., spinal stenosis, fibromyalgia or arthritis]), that may interfere with judging PDPN-related pain
- •4. Current or previous foot ulcer as determined by medical history and medical examination
- •5. Any amputation of lower extremity
- •6. Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated according to the Cockcroft-Gault formula
- •7. 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
- •8. 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)
- •9. Clinically significant foot deformities, including hallux rigidus, hallux valgus, or rigid toe as determined by physical examination as judged by the investigator
- •10. 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
- •11. Any active signs of skin inflammation around onychomycosis sites such as pain, redness, swelling or drainage
- •12. Subject is unwilling to implement proper foot care methods
- •13. Clinically significant abnormal ECG at screening
- •14. Impaired glucose tolerance (IGT) only - without DM
- •15. Body mass index (BMI) of >=40 kg/m2
- •16. Diagnosis of any poorly controlled major psychiatric disorder
- •17. Evidence of cognitive impairment including dementia that may interfere with subject*s ability to complete pain assessments requiring subject*s recall of average pain level in the past 24 hours
- •18. 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
- •19. Participation in any other clinical trial for an investigational drug within 30 days prior to screening visit
- •20. Previous treatment with QUTENZA
- •21. Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, so
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