NCT00385671已完成4 期
An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
研究概览
简要总结
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
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
- None
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
- •You must have been diagnosed with Diabetic Neuropathic Pain
- •Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
- •Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
- •Patient must agree not to change dose of gabapentin between Visits 1 and 2
- •You must have stable glycemic control
排除标准
- •Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
- •Current diagnosis or history of hemangiosarcoma
- •Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
- •Patients with uncontrolled narrow-angle glaucoma
- •Presence of a current seizure disorder
研究组 & 干预措施
Pregabalin
Active Comparator
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
干预措施: pregabalin (Drug)
Duloxetine
Experimental
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
干预措施: duloxetine hydrochloride (Drug)
Gabapentin + Duloxetine
Experimental
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
干预措施: duloxetine hydrochloride (Drug)
Gabapentin + Duloxetine
Experimental
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
干预措施: gabapentin (Drug)
结局指标
主要结局
Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
时间窗: baseline, 12 weeks
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
次要结局
- Mean Change From Baseline to 12 Weeks in Body Weight(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)(baseline, 12 weeks)
- Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks(12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain(baseline, 12 Weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score(baseline, 12 weeks)
- Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks(baseline, 12 weeks)
- Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score(baseline, 12 weeks)
- Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3(baseline, 12 weeks)
- Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores(baseline, 12 weeks)
- Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores(baseline, 12 weeks)
- Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores(baseline, 12 weeks)
- Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score(baseline, 12 weeks)
- Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale(baseline, 12 weeks)
- Summary of Number of Participants Who Discontinued(baseline through 12 weeks)
- Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score(baseline through 12 weeks)
- Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score(baseline through 12 weeks)
- Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score(baseline through 12 weeks)
- Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score(baseline through 12 weeks)
- Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)(baseline, 12 weeks)
- Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)(baseline, 12 weeks)
- Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)(baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks)
- Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Blood Pressure(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Heart Rate(baseline through 12 weeks)
- Number of Participants With Treatment-emergent Elevated Blood Pressure(baseline through 12 weeks)
- Number of Participants With Treatment-Emergent Elevated Heart Rate(baseline through 12 weeks)
- Number of Participants With Treatment-Emergent Changes in Body Weight(baseline through 12 weeks)
- Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Total Bilirubin(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose(baseline, 12 weeks)
- Mean Change From Baseline to 12 Weeks in Hemoglobin A1C(baseline, 12 weeks)
- Number of Patients With Treatment-Emergent Elevated Laboratory Analytes(baseline through 12 weeks)
研究者
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