Skip to main content
OpenTrials
Completed

NCT Number: NCT00641719

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duloxetine hydrochloride

Drug

Duloxetine 40 mg QD, PO, 1 year

Other names: LY248686, Cymbalta

Primary outcomes

  1. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: baseline through 1 year

    See the Reported Adverse Events section for details.

Secondary outcomes

  1. Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.

    Time frame: 1 year

    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).

  2. Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale

    Time frame: baseline, 1 year

    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).

  3. Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint

    Time frame: 1 year

    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.

  4. Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores

    Time frame: baseline, 1 year

    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.

  5. Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint

    Time frame: 1 year

    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).

  6. Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores

    Time frame: baseline, 1 year

    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. Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint

    Time frame: 1 year

    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.

  8. Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score

    Time frame: baseline, 1 year

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Shionogi

Registry information

Official study title

A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2008
Registry last updated
Mar 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.