NCT01179672已完成3 期
Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
研究概览
简要总结
The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with pain due to bilateral peripheral neuropathy
- •Participants must have pain caused by Type 1 or Type 2 diabetes mellitus
- •Pain must begin in the feet with relatively symmetrical onset
- •Daily pain should be present for at least 6 months
- •Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory (MNSI)
- •Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
- •Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) <12% before randomization
- •Score of greater than or equal to 4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Screening.
- •Full completion of the daily diaries for at least 80% of the days between the second and third time you come to the hospital (Screening).
排除标准
- •Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Current (less than or equal to 1 year) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis of major depressive disorder, dysthymia, anxiety disorders (excluding phobias), alcohol or eating disorders as determined by the Mini-International Neuropsychiatric Interview (MINI) or a previous diagnosis
- •DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by participant history or by diagnosis using specific MNSI modules
- •Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychological conditions that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
- •At Screening alanine transaminase (ALT) greater than 2 times upper limit of normal (ULN), based on central laboratory reference ranges times ULN, based on central laboratory reference ranges
- •Prior renal transplant, current renal dialysis, or serum creatinine laboratory value >1.5 times ULN, based on central laboratory reference ranges at Screening.
- •Historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
- •Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
- •Participants who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including participants who participated in study F1J-MC-HMEQ (NCT00408993), even those in the placebo arm
- •Participants taking excluded medications that cannot be stopped at Screening
- •Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of the third Screening
- •Participants with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:
- •Hepatic dysfunction as determined by the investigator or
- •Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
- •Aspartate transaminase (AST), ALT, or bilirubin above the normal reference range.
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
时间窗: Baseline, 12 weeks
24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
次要结局
- Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain(Baseline, 12 weeks)
- Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain(Baseline, 12 weeks)
- Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale(Baseline, 12 weeks)
- Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale(Baseline, 12 weeks)
- Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint(12 weeks)
- Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score(Baseline, 12 weeks)
- Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ(Baseline, 12 weeks)
- Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score(Baseline, 12 weeks)
- Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score(Baseline, 12 weeks)
研究者
研究点 (1)
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