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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
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathies
Depressive Disorder, Major
 Drug: Duloxetine 60 mg QD
Drug: Duloxetine 30 mg QD
Drug: Duloxetine 90 mg QD
Drug: Duloxetine 120 mg QD
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in BPI Worst Pain During Treatment From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Worst Pain (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Worst Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Least Pain (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Least Pain During Treatment (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Least Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Average Pain (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Average Pain During Treatment (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Average Pain (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Number of Patients With a Reduction in BPI Average Pain at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  • Number of Patients With a Reduction in BPI Average Pain at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Number of Patients With a Reduction in BPI Average Pain at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Pain During Treatment (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Pain (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Pain During Treatment (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

  • Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

  • Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

  • Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

  • Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

  • Patient Global Impression - Improvement (PGI-I) at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  • Patient Global Impression - Improvement (PGI-I) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  • Patient Global Impression - Improvement (PGI-I) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  • Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

  • Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

  • Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

  • Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

  • Change in HADS Anxiety Total Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

  • Change in HADS Anxiety Total Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

  • Change in HADS Depression Total Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

  • Change in HADS Depression Total Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

  • Change in HADS Depression Total Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

  • Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

  • Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

  • Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

  • Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

  • Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

  • Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

  • Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

  • Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

  • Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).

  • Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

  • Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

  • Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

  • Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

  • Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

  • Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • 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 ] [ Designated as safety issue: No ]
    Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • 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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

  • Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

  • Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

  • Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

  • Change in Hamilton Depression Score From Baseline to Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

  • Change in Hamilton Depression Score From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

  • Change in Hamilton Depression Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

  • Suicidal Thoughts by BDI-II at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Suicidal Thoughts by BDI-II at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Suicidal Thoughts by BDI-II at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change of Fasting Blood Glucose From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Ancova analysis controlling for baseline and insulin intake

  • Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Ancova analysis controlling for baseline and insulin intake

  • Change of Systolic Blood Pressure From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change of Diastolic Blood Pressure From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change of Pulse Rate From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: February 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
 Drug: Duloxetine 60 mg QD
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
Drug: Duloxetine 30 mg QD
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
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)
 Drug: Duloxetine 90 mg QD
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
Drug: Duloxetine 60 mg QD
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
Drug: Duloxetine 30 mg QD
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
Drug: Duloxetine 120 mg QD
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerared
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)
 Drug: Duloxetine 60 mg QD
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
Drug: Duloxetine 30 mg QD
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
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)
 Drug: Duloxetine 90 mg QD
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
Drug: Duloxetine 60 mg QD
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
Drug: Duloxetine 120 mg QD
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
Drug: Duloxetine 30 mg QD
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
  2. To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
  3. Male or female outpatients at least 18 years of age.
  4. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
  5. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
  6. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Exclusion criteria:

  1. Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
  2. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
  3. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
  4. Have previously been treated with duloxetine (for DPNP or MDD)
  5. Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
  6. Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844194

Locations
Germany
1208.34.49008 Boehringer Ingelheim Investigational Site
Achim bei Bremen, Germany
1208.34.49025 Boehringer Ingelheim Investigational Site
Aschaffenburg, Germany
1208.34.49001 Boehringer Ingelheim Investigational Site
Bad Mergentheim, Germany
1208.34.49018 Boehringer Ingelheim Investigational Site
Baesweiler, Germany
1208.34.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
1208.34.49005 Boehringer Ingelheim Investigational Site
Berlin, Germany
1208.34.49009 Boehringer Ingelheim Investigational Site
Berlin, Germany
1208.34.49007 Boehringer Ingelheim Investigational Site
Berlin-Steglitz, Germany
1208.34.49021 Boehringer Ingelheim Investigational Site
Bremen, Germany
1208.34.49028 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1208.34.49012 Boehringer Ingelheim Investigational Site
Gera, Germany
1208.34.49020 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1208.34.49023 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1208.34.49004 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1208.34.49015 Boehringer Ingelheim Investigational Site
Hattingen, Germany
1208.34.49027 Boehringer Ingelheim Investigational Site
Heidenheim, Germany
1208.34.49016 Boehringer Ingelheim Investigational Site
Kelkheim, Germany
1208.34.49006 Boehringer Ingelheim Investigational Site
Limburgerhof, Germany
1208.34.49022 Boehringer Ingelheim Investigational Site
Münster, Germany
1208.34.49019 Boehringer Ingelheim Investigational Site
Neuwied, Germany
1208.34.49024 Boehringer Ingelheim Investigational Site
St. Ingberg, Germany
1208.34.49010 Boehringer Ingelheim Investigational Site
Stuhr, Germany
1208.34.49013 Boehringer Ingelheim Investigational Site
Unterhaching, Germany
1208.34.49029 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1208.34.49026 Boehringer Ingelheim Investigational Site
Wuppertal, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Diabetic Neuropathies
Neuralgia
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
 Neurologic Manifestations
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 23, 2013