Skip to main content
OpenTrials
Completed

NCT Number: NCT00408993

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.

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

18 year and older

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., Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
  • May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
  • Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion criteria

  • Glycosylated hemoglobin (A1C) > 12%
  • Severe hepatic disease
  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  • Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
  • Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
  • Treatment of fluoxetine within 30 days of starting the study.
  • Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Treatment and study plan

duloxetine hydrochloride

Drug

60 mg every day (QD) (morning or evening), by mouth (PO)

Other names: LY248686, Cymbalta

Placebo

Drug

Placebo every day (QD), by mouth (PO)

Primary outcomes

  1. Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score

    Time frame: Baseline and 12 weeks

    A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Secondary outcomes

  1. Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores

    Time frame: Baseline and 12 weeks

    Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).

  2. Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity

    Time frame: Baseline and 12 weeks

    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

  3. Time Course of Change in Patient Global Impression - Improvement Scale

    Time frame: baseline, over 12 weeks

    A scale that measures the patient'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).

  4. Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)

    Time frame: Baseline and 12 weeks

    The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.

  5. Number of Participants Discontinuing Due to Adverse Events

    Time frame: over 12 weeks

  6. Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)

    Time frame: over 12 weeks

    Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.

  7. Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item

    Time frame: Baseline and 12 weeks

    Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.

  8. Vital Signs - Weight

    Time frame: Baseline and 12 weeks

    Change from baseline to endpoint in body weight.

  9. Vital Signs - Pulse Rate

    Time frame: Baseline and 12 weeks

    Change from baseline to endpoint in pulse rate.

  10. Vital Signs - Blood Pressure

    Time frame: Baseline and 12 weeks

    Change from baseline to endpoint in systolic and diastolic blood pressure.

  11. Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides

    Time frame: Baseline and 12 weeks

    Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.

  12. Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid

    Time frame: Baseline and 12 weeks

    Significantly different laboratory values between the two groups in baseline to endpoint changes

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 8, 2006
Registry last updated
Jul 26, 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.