NCT01087203终止2 期
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 73
- 试验地点
- 95
- 主要终点
- Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.
详细描述
This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.
- •Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.
- •Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
- •A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.
- •Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.
排除标准
- •Painful neuropathies other than diabetic peripheral neuropathy.
- •Other types of diabetic neuropathies.
- •Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.
- •Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.
- •Patients with a present (current) history of sciatica are not eligible for participation.
- •The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.
- •Amputations dues to diabetes.
- •Patient with any clinically significant medical condition or laboratory abnormalities.
- •History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
- •History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).
- •History of known alcohol, analgesic or drug abuse within 2 years of Screening.
- •Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
结局指标
主要结局
Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
时间窗: Baseline, Week 16
Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).
次要结局
- Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12(Baseline, Week 1, 2, 4, 6, 8, 12)
- Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16(Week 16)
- Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)(Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16(Baseline, Week 8, 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)(Baseline, Week 8, 16)
- Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16(Baseline, Week 8, 16)
- Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16(Baseline, Week 4, 8, 12, 16)
- Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy(Week 4, 8, 12, 16)
- Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16(Baseline, Week 16)
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 16)
- Number of Participants Who Used Rescue Medication(Week 1, 2, 4, 6, 8, 12, 16)
- Days Per Week of Rescue Medication Usage(Week 1, 2, 4, 6, 8, 12, 16)
- Amount of Rescue Medication Taken(Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 112 days after last dose of study treatment (up to 169 days))
- Number of Participants With Clinically Significant Laboratory Values(Baseline up to Week 24)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to Week 24)
- Number of Participants With Clinically Significant Change From Baseline Physical Examination(Baseline up to Week 24)
- Number of Participants With Clinically Significant Vital Signs Abnormalities(Baseline up to Week 24)
- Number of Participants With Anti Drug Antibody (ADA) for Tanezumab(Baseline, Week 8, 16, 24)
- Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)(Baseline, Weeks 2, 4, 8, 12, 16 and 24)
- Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)(Baseline, Week 16)
- Change From Baseline in Quantitative Sensory Testing (QST) at Week 16(Baseline, Week 16)
- Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF(Baseline, Week 16)
- Plasma Tanezumab Concentration(Baseline(Day 1), Week 2, 4, 8, 12, 16, 24)
- Serum Nerve Growth Factor (NGF)(Day 1, Week 8, 16, 24)
研究者
研究点 (95)
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