A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disorder. The Primary Objective of This Study is to Evaluate Whether the Efficacy of Duloxetine Given as 60 mg to 120 mg Once Daily (QD), Measured by the BPI Interference Score After 12 Weeks Shows a Clinically Relevant Improvement in the DPNP Patients With Co-morbid MDD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 25
- 主要终点
- Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
研究概览
简要总结
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis.
As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain.
The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI).
As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale.
Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated.
To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DPNP with depression (1)
Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
干预措施: Duloxetine 60 mg QD (Drug)
DPNP with depression (1)
Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
干预措施: Duloxetine 30 mg QD (Drug)
DPNP with depression (2)
Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 90 mg QD (Drug)
DPNP with depression (2)
Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 60 mg QD (Drug)
DPNP with depression (2)
Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 30 mg QD (Drug)
DPNP with depression (2)
Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 120 mg QD (Drug)
DPNP without depression (2)
Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 120 mg QD (Drug)
DPNP without depression (1)
Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
干预措施: Duloxetine 60 mg QD (Drug)
DPNP without depression (1)
Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
干预措施: Duloxetine 30 mg QD (Drug)
DPNP without depression (2)
Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 90 mg QD (Drug)
DPNP without depression (2)
Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 60 mg QD (Drug)
DPNP without depression (2)
Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
干预措施: Duloxetine 30 mg QD (Drug)
结局指标
主要结局
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
时间窗: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
次要结局
- Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6(Baseline and Week 6)
- Change in BPI Worst Pain During Treatment From Baseline to Week 2(Baseline and Week 2)
- Change in Worst Pain (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Worst Pain (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Least Pain (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Least Pain During Treatment (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Least Pain (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Average Pain (BPI) From Baseline to Week 2(Baseline and Week 2)
- Suicidal Thoughts or Behaviours by HAMD-17 at Week 2(Week 2)
- Change in Average Pain During Treatment (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Average Pain (BPI) From Baseline to Week 12(Baseline and Week 12)
- Number of Patients With a Reduction in BPI Average Pain at Week 2(Baseline and Week 2)
- Number of Patients With a Reduction in BPI Average Pain at Week 6(Baseline and Week 6)
- Number of Patients With a Reduction in BPI Average Pain at Week 12(Baseline and Week 12)
- Change in Pain During Treatment (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Pain (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Pain During Treatment (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2(Baseline and Week 2)
- Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6(Baseline and Week 6)
- Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12(Baseline and Week 12)
- Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Mood (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Mood (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Mood (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12(Baseline and Week 12)
- Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2(Baseline and Week 2)
- Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6(Baseline and Week 6)
- Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12(Baseline and Week 12)
- Patient Global Impression - Improvement (PGI-I) at Week 2(Baseline and Week 2)
- Patient Global Impression - Improvement (PGI-I) at Week 6(Baseline and Week 6)
- Patient Global Impression - Improvement (PGI-I) at Week 12(Baseline and Week 12)
- Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2(Baseline and Week 2)
- Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6(Baseline and Week 6)
- Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12(Baseline and Week 12)
- Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2(Baseline and Week 2)
- Change in HADS Anxiety Total Score From Baseline to Week 6(Baseline and Week 6)
- Change in HADS Anxiety Total Score From Baseline to Week 12(Baseline and Week 12)
- Change in HADS Depression Total Score From Baseline to Week 2(Baseline and Week 2)
- Change in HADS Depression Total Score From Baseline to Week 6(Baseline and Week 6)
- Change in HADS Depression Total Score From Baseline to Week 12(Baseline and Week 12)
- Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6(Baseline and Week 6)
- Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12(Baseline and Week 12)
- Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6(Baseline and Week 6)
- Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12(Baseline and Week 12)
- Suicidal Thoughts or Behaviours by HAMD-17 at Week 6(Week 6)
- Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12(Baseline and Week 12)
- Suicidal Thoughts or Behaviours by HAMD-17 at Week 12(Week 12)
- Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12(Baseline and Week 12)
- Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6(Baseline and Week 6)
- Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12(Baseline and Week 12)
- Change in Clinical Global Impression - Severity Pain From Baseline to Week 2(Baseline and Week 2)
- Change in Clinical Global Impression - Severity Pain From Baseline to Week 6(Baseline and Week 6)
- Change in Clinical Global Impression - Severity Pain From Baseline to Week 12(Baseline and Week 12)
- Change in Hamilton Depression Score From Baseline to Week 2(Baseline and Week 2)
- Change in Hamilton Depression Score From Baseline to Week 6(Baseline and Week 6)
- Change in Hamilton Depression Score From Baseline to Week 12(Baseline and Week 12)
- Suicidal Thoughts by BDI-II at Week 2(Week 2)
- Suicidal Thoughts by BDI-II at Week 6(Week 6)
- Suicidal Thoughts by BDI-II at Week 12(Week 12)
- Change of Fasting Blood Glucose From Baseline at Week 12(Baseline and Week 12)
- Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12(Baseline and Week 12)
- Change of Systolic Blood Pressure From Baseline at Week 12(Baseline and Week 12)
- Change of Diastolic Blood Pressure From Baseline at Week 12(Baseline and Week 12)
- Change of Pulse Rate From Baseline at Week 12(Baseline and Week 12)