Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00844194

First received: February 13, 2009

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Diabetic Neuropathies Depressive Disorder, Major
Interventions:	Drug: Duloxetine 60 mg QD Drug: Duloxetine 30 mg QD Drug: Duloxetine 90 mg QD Drug: Duloxetine 120 mg QD

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Without Major Depressive Disorder (MDD-)	Patients with diabetic polyneuropathy and no depression
With Major Depressive Disorder (MDD+)	Patients with diabetic polyneuropathy and depression

Participant Flow: Overall Study

	Without Major Depressive Disorder (MDD-)	With Major Depressive Disorder (MDD+)
STARTED	78	30
COMPLETED	53	22
NOT COMPLETED	25	8
Adverse Event	17	5
Protocol Violation	1	1
Lost to Follow-up	1	1
Withdrawal by Subject	2	1
Lack of Efficacy	3	0
Other reason (not specified)	1	0

Baseline Characteristics

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Reporting Groups

	Description
Without Major Depressive Disorder (MDD-)	Patients with diabetic polyneuropathy and no depression
With Major Depressive Disorder (MDD+)	Patients with diabetic polyneuropathy and depression
Total	Total of all reporting groups

Baseline Measures

	Without Major Depressive Disorder (MDD-)	With Major Depressive Disorder (MDD+)	Total
Number of Participants [units: participants]	78	30	108
Age [units: Years] Mean ± Standard Deviation	67.5 ± 10.2	66.6 ± 9.8	67.3 ± 10.1
Gender [units: Participants]
Female	36	15	51
Male	42	15	57

Outcome Measures

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1. Primary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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2. Primary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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Measure Type	Primary
Measure Title	Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
Measure Description	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).
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Reporting Groups

	Description
MDD- Responder	MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
MDD+ Responder	MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
MDD- Non-Responder	MDD-, not treatment responder. 60mg, after week 5 120mg DLX
MDD+ Non-Responder	MDD+, not treatment responder. 60mg, after week 5 120mg DLX

Measured Values

	MDD- Responder	MDD+ Responder	MDD- Non-Responder	MDD+ Non-Responder
Number of Participants Analyzed [units: participants]	41	18	19	6
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 [units: Scores on a scale] Mean ± Standard Deviation	-1.7 ± 1.65	-2.2 ± 2.0	-0.9 ± 2.5	-2.6 ± 3.31

No statistical analysis provided for Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12

3. Secondary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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4. Secondary:

Change in BPI Worst Pain During Treatment From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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5. Secondary:

Change in Worst Pain (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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6. Secondary:

Change in Worst Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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7. Secondary:

Change in Least Pain (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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8. Secondary:

Change in Least Pain During Treatment (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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9. Secondary:

Change in Least Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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10. Secondary:

Change in Average Pain (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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11. Secondary:

Change in Average Pain During Treatment (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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12. Secondary:

Change in Average Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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13. Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 2 [ Time Frame: Baseline and Week 2 ]

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14. Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 6 [ Time Frame: Baseline and Week 6 ]

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15. Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 12 [ Time Frame: Baseline and Week 12 ]

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16. Secondary:

Change in Pain During Treatment (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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17. Secondary:

Change in Pain (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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18. Secondary:

Change in Pain During Treatment (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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19. Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 [ Time Frame: Baseline and Week 2 ]

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20. Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 [ Time Frame: Baseline and Week 6 ]

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21. Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 [ Time Frame: Baseline and Week 12 ]

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22. Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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23. Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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24. Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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25. Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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26. Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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27. Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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28. Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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29. Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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30. Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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31. Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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32. Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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33. Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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34. Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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35. Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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36. Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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37. Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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38. Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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39. Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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40. Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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41. Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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42. Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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43. Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 2 [ Time Frame: Baseline and Week 2 ]

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44. Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 6 [ Time Frame: Baseline and Week 6 ]

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45. Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 12 [ Time Frame: Baseline and Week 12 ]

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46. Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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47. Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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48. Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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49. Secondary:

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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50. Secondary:

Change in HADS Anxiety Total Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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51. Secondary:

Change in HADS Anxiety Total Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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52. Secondary:

Change in HADS Depression Total Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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53. Secondary:

Change in HADS Depression Total Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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54. Secondary:

Change in HADS Depression Total Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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55. Secondary:

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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56. Secondary:

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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57. Secondary:

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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58. Secondary:

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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59. Secondary:

Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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60. Secondary:

Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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61. Secondary:

Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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62. Secondary:

Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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63. Secondary:

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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64. Secondary:

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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65. Secondary:

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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66. Secondary:

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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67. Secondary:

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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68. Secondary:

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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69. Secondary:

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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70. Secondary:

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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71. Secondary:

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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72. Secondary:

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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73. Secondary:

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 [ Time Frame: Baseline and Week 6 ]

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74. Secondary:

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75. Secondary:

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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76. Secondary:

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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77. Secondary:

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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78. Secondary:

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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79. Secondary:

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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80. Secondary:

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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81. Secondary:

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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82. Secondary:

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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83. Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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84. Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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85. Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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86. Secondary:

Change in Hamilton Depression Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]

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87. Secondary:

Change in Hamilton Depression Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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88. Secondary:

Change in Hamilton Depression Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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89. Secondary:

Suicidal Thoughts by BDI-II at Week 2 [ Time Frame: Week 2 ]

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90. Secondary:

Suicidal Thoughts by BDI-II at Week 6 [ Time Frame: Week 6 ]

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91. Secondary:

Suicidal Thoughts by BDI-II at Week 12 [ Time Frame: Week 12 ]

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92. Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 [ Time Frame: Week 2 ]

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93. Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 [ Time Frame: Week 6 ]

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94. Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 [ Time Frame: Week 12 ]

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95. Secondary:

Change of Fasting Blood Glucose From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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96. Secondary:

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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97. Secondary:

Change of Systolic Blood Pressure From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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98. Secondary:

Change of Diastolic Blood Pressure From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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99. Secondary:

Change of Pulse Rate From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00844194 History of Changes
Other Study ID Numbers:	1208.34, 2008-002731-32
Study First Received:	February 13, 2009
Results First Received:	June 7, 2011
Last Updated:	May 18, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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