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

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408993
• Other study ID #: 10599
• Secondary ID: F1J-MC-HMEQ(a)
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: July 22, 2011
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia

Intervention

Drug:
• Duloxetine Hydrochloride
60 mg every day (QD) (morning or evening), by mouth (PO)
• Placebo
Placebo every day (QD), by mouth (PO)

Locations

Country	Name	City	State
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	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	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	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	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	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	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Boehringer Ingelheim

Country where clinical trial is conducted

China, 

References & Publications (1)

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score	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).	Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores	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).	Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity	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.	Baseline and 12 weeks	No
Secondary	Time Course of Change in Patient Global Impression - Improvement Scale	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).	baseline, over 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)	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.	Baseline and 12 weeks	No
Secondary	Number of Participants Discontinuing Due to Adverse Events		over 12 weeks	Yes
Secondary	Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)	Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.	over 12 weeks	Yes
Secondary	Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item	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.	Baseline and 12 weeks	No
Secondary	Vital Signs - Weight	Change from baseline to endpoint in body weight.	Baseline and 12 weeks	Yes
Secondary	Vital Signs - Pulse Rate	Change from baseline to endpoint in pulse rate.	Baseline and 12 weeks	Yes
Secondary	Vital Signs - Blood Pressure	Change from baseline to endpoint in systolic and diastolic blood pressure.	Baseline and 12 weeks	Yes
Secondary	Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides	Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.	Baseline and 12 weeks	Yes
Secondary	Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid	Significantly different laboratory values between the two groups in baseline to endpoint changes	Baseline and 12 weeks	Yes