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A Long-term Study for the Treatment of Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00641719
First received: March 19, 2008
Last updated: March 3, 2011
Last verified: March 2011
Results First Received: March 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Neuropathies
Intervention: Drug: Duloxetine hydrochloride

  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
This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.

Reporting Groups
  Description
Duloxetine 40 mg Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg Duloxetine 60 mg QD, PO, 1 year

Participant Flow:   Overall Study
    Duloxetine 40 mg   Duloxetine 60 mg
STARTED   129   129 
COMPLETED   99   92 [1] 
NOT COMPLETED   30   37 
Lack of Efficacy                1                2 
Adverse Event                24                29 
Withdrawal by Subject                4                4 
Reason Not Specified                1                2 
[1] 1 participant discontinued during taper phase, not during treatment phase.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Duloxetine 40 mg Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg Duloxetine 60 mg QD, PO, 1 year
Total Total of all reporting groups

Baseline Measures
   Duloxetine 40 mg   Duloxetine 60 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   129   258 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (10.5)   60.0  (9.6)   60.1  (10.0) 
Gender 
[Units: Participants]
     
Female   40   22   62 
Male   89   107   196 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 129   129   258 
[1] All participants were Japanese.
Region of Enrollment 
[Units: Participants]
     
Japan   129   129   258 
Duration of Diabetes 
[Units: Participants]
     
Less Than 5 Years   23   25   48 
5 to 10 Years   27   23   50 
Greater Than or Equal to 10 Years   76   79   155 
Unknown   3   2   5 
Type of Diabetes [1] 
[Units: Participants]
     
Type I   8   4   12 
Type II   121   125   246 
[1] Type I diabetes is insulin dependent diabetes. Type II diabetes is non-insulin dependent diabetes.
Height 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 163.69  (9.04)   165.12  (7.75)   164.41  (8.44) 
Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 63.91  (12.13)   64.98  (11.57)   64.45  (11.84) 
Body Mass Index (BMI) [1] 
[Units: Kilograms/meters squared (kg/m^2)]
Mean (Standard Deviation)
 23.79  (3.77)   23.77  (3.49)   23.78  (3.62) 
[1] Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared (kg/m^2).
Duration of Diabetic Neuropathy 
[Units: Years]
Mean (Standard Deviation)
 3.91  (3.16)   4.29  (3.91)   4.10  (3.55) 
Patient's Global Impressions of Improvement (PGI-I) Rate [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.0  (1.1)   3.1  (1.1)   3.1  (1.1) 
[1] A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Beck Depression Inventory - II (BDI-II) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.1  (6.4)   6.1  (6.4)   6.1  (6.4) 
[1] A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Brief Pain Inventory (BPI) Interference [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
General Activity   2.5  (2.4)   2.7  (2.2)   2.6  (2.3) 
Mood   2.3  (2.3)   2.4  (2.2)   2.3  (2.2) 
Walking Ability   2.2  (2.4)   2.3  (2.1)   2.3  (2.2) 
Normal Work   2.3  (2.3)   2.3  (2.2)   2.3  (2.3) 
Relation to People   1.6  (2.1)   1.9  (2.1)   1.8  (2.1) 
Sleep   2.2  (2.3)   2.5  (2.4)   2.3  (2.4) 
Enjoyment of Life   1.9  (2.1)   2.1  (2.1)   2.0  (2.1) 
Average Interference Score   2.14  (2.09)   2.32  (2.06)   2.23  (2.07) 
[1] Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Brief Pain Inventory (BPI) - Pain Severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Worst Pain   4.7  (2.0)   4.9  (2.0)   4.8  (2.0) 
Least Pain   2.8  (2.0)   3.1  (2.1)   3.0  (2.0) 
Average Pain   3.8  (1.9)   4.0  (1.9)   3.9  (1.9) 
Pain Right Now   3.4  (2.1)   3.6  (2.1)   3.5  (2.1) 
[1] A self-reported scale that measures the severity of pain based on the average pain, least pain, and worst pain experienced over the past 24 hours, and the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).


  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: baseline through 1 year ]

2.  Secondary:   Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.   [ Time Frame: 1 year ]

3.  Secondary:   Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale   [ Time Frame: baseline, 1 year ]

4.  Secondary:   Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint   [ Time Frame: 1 year ]

5.  Secondary:   Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores   [ Time Frame: baseline, 1 year ]

6.  Secondary:   Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint   [ Time Frame: 1 year ]

7.  Secondary:   Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores   [ Time Frame: baseline, 1 year ]

8.  Secondary:   Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint   [ Time Frame: 1 year ]

9.  Secondary:   Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score   [ Time Frame: baseline, 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00641719     History of Changes
Other Study ID Numbers: 12194
F1J-JE-HMFY ( Other Identifier: Eli Lilly and Company )
Study First Received: March 19, 2008
Results First Received: March 3, 2011
Last Updated: March 3, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare