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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

March 19, 2008
March 3, 2011
March 2008
March 2010   (final data collection date for primary outcome measure)
Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: baseline through 1 year ] [ Designated as safety issue: Yes ]
See the Reported Adverse Events section for details.
Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00641719 on ClinicalTrials.gov Archive Site
  • Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale [ Time Frame: baseline, 1 year ] [ Designated as safety issue: No ]
    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).
  • Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
  • Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores [ Time Frame: baseline, 1 year ] [ Designated as safety issue: No ]
    A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
  • Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores [ Time Frame: baseline, 1 year ] [ Designated as safety issue: No ]
    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).
  • Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score [ Time Frame: baseline, 1 year ] [ Designated as safety issue: No ]
    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.
  • Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Brief Pain Inventory to measure the severity of pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) total score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Neuropathies
  • Drug: Duloxetine hydrochloride
    Duloxetine 40 mg QD, PO, 1 year
    Other Names:
    • LY248686
    • Cymbalta
  • Drug: Duloxetine hydrochloride
    Duloxetine 60 mg QD, PO, 1 year
    Other Names:
    • LY248686
    • Cymbalta
  • Experimental: Duloxetine 40 mg
    Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year
    Intervention: Drug: Duloxetine hydrochloride
  • Experimental: Duloxetine 60 mg
    Duloxetine 60 mg QD, PO, 1 year
    Intervention: Drug: Duloxetine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
  • Patients who desire to receive continued treatment with LY248686 from the preceding study.
  • Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
  • Patients who can provide written consent in person.

Exclusion Criteria:

  • Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
  • Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
  • Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00641719
12194, F1J-JE-HMFY
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Shionogi
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP