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

History of Changes

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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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
Number of Participants [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
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 ^[2] [units: participants]
Type I	8	4	12
Type II	121	125	246
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) ^[3] [units: kilograms/meters squared (kg/m^2)] Mean ± Standard Deviation	23.79 ± 3.77	23.77 ± 3.49	23.78 ± 3.62
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 ^[4] [units: units on a scale] Mean ± Standard Deviation	3.0 ± 1.1	3.1 ± 1.1	3.1 ± 1.1
Beck Depression Inventory - II (BDI-II) ^[5] [units: units on a scale] Mean ± Standard Deviation	6.1 ± 6.4	6.1 ± 6.4	6.1 ± 6.4
Brief Pain Inventory (BPI) Interference ^[6] [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
Brief Pain Inventory (BPI) - Pain Severity ^[7] [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]	All participants were Japanese.
[2]	Type I diabetes is insulin dependent diabetes. Type II diabetes is non-insulin dependent diabetes.
[3]	Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared (kg/m^2).
[4]	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).
[5]	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.
[6]	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).
[7]	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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

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9. Secondary:

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

Show Outcome Measure 9

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.

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00641719 History of Changes
Other Study ID Numbers:	12194, F1J-JE-HMFY
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

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