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

• ClinicalTrials.gov Identifier: NCT00408993
• Recruitment Status: Completed
• First Posted: December 8, 2006
• Results First Posted: June 2, 2009
• Last Update Posted: July 26, 2011
• Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Information provided by: Eli Lilly and Company

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diabetic Neuropathies	Drug: Duloxetine Hydrochloride; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
• Study Start Date: December 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Duloxetine; 60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)	Drug: Duloxetine Hydrochloride; 60 mg every day (QD) (morning or evening), by mouth (PO); Other Names: LY248686; Cymbalta
Placebo Comparator: Placebo; Placebo every day (QD), by mouth (PO) for 12 weeks	Drug: Placebo; Placebo every day (QD), by mouth (PO)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China

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, 100101

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.

Changsha, China, 410011

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.

Harbin, China, 150086

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.

Nanjing, China, 210029

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.

Nanjin, China, 210012

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.

Shanghai, China, 200233

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.

Wu Han, China, 430022

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

More Information

Publications of Results:

Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92.

• Responsible Party: Chief Medical Officer, Eli Lilly
• ClinicalTrials.gov Identifier: NCT00408993
• Other Study ID Numbers: 10599; F1J-MC-HMEQ(a) ( Other Identifier: Eli Lilly and Company )
• First Posted: December 8, 2006
• Results First Posted: June 2, 2009
• Last Update Posted: July 26, 2011
• Last Verified: July 2011

Additional relevant MeSH terms:

Neuralgia; Diabetic Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Duloxetine Hydrochloride; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs; Dopamine Agents