A Post-Market Observational Multi-Center Study to Evaluate the Effectiveness of Repeated QUTENZA Use in Adults With Painful Diabetic Peripheral Neuropathy of the Feet
概览
- 阶段
- 不适用
- 干预措施
- Capsaicin 8%
- 疾病 / 适应症
- Peripheral Diabetic Neuropathy
- 发起方
- Averitas Pharma, Inc.
- 入组人数
- 144
- 试验地点
- 28
- 主要终点
- Change (%) in pain intensity post QUTENZA administrations
- 状态
- 进行中（未招募）
- 最后更新
- 11天前
概览
简要总结
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
研究者
入排标准
入选标准
- •IRB approved written Informed Consent and privacy language as per national regulations will be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
- •Male or female 18 - 80 years of age
- •Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes confirmed by the Douleur Neuropathique 4 Interview (DN4I) of at least 3 out of 7
- •Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during the screening period
- •Stable doses of pain medications for PDPN for more than 4 weeks prior to the screening visit
- •Patient agreed not to participate in another interventional study while on treatment
排除标准
- •Pain associated with PDPN in the ankles or above
- •Pain that could not be clearly differentiated from, or conditions that might have interfered with the assessment of the 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 (eg, phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (eg, plantar ulcer)
- •Significant pain (moderate or above) of an etiology other than PDPN (eg, compression-related neuropathies \[eg, spinal stenosis\]), fibromyalgia or arthritis, that may interfere with assessment of PDPN-related pain
- •Current foot ulcer or not intact skin as determined by medical examination
- •Clinically significant foot deformities or foot amputations
- •Any active signs of skin inflammation around onychomycosis sites such as pain, redness, swelling or drainage
- •Patient is unwilling to implement proper foot care methods
- •Diagnosis of any poorly controlled major psychiatric disorder at the Investigator's discretion
- •Evidence of cognitive impairment including dementia that may interfere with patient's ability to complete pain assessments requiring patient's recall of average pain level in the past 24 hours
- •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 have reoccurred during the study period as judged by the Investigator
研究组 & 干预措施
Study group
All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications).
干预措施: Capsaicin 8%
结局指标
主要结局
Change (%) in pain intensity post QUTENZA administrations
时间窗: Baseline, weeks 2-12 Post-Admin
The pain intensity score from baseline will be compared to the average weekly pain intensity score between weeks 2-12 post each QUTENZA application (up to 3 applications).
Change (%) in overall scores for Patient-Report Outcomes Measurement Information System (PROMIS)-29
时间窗: Baseline, week 12 Post-Admin
The baseline PROMIS-29 scores for all domains will be compared to the PROMIS-29 scores assessed at 12 weeks post-each QUTENZA application (up to 3 applications).
Total number of patients who completed each QUTENZA treatment.
时间窗: week 12 Post-Admin
Analysis of the number of patients who completed repeated (2 or 3) QUTENZA applications.
Change (%) of concomitant medications at baseline and 12 weeks after each treatment
时间窗: through study completion, an average of 36 weeks
The change in utilization of pharmaceutical drug by medication, pharmacology class, dose, and frequency of use for drugs for PDPN, documented by collecting Concomitant medications including indication (for PDPN, for other reasons, and for temporary rescue use for PDPN) and dose