Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00408993

Purpose

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

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: Duloxetine Hydrochloride Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-Hour Average Pain Score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Time Course of Change in Patient Global Impression - Improvement Scale [ Time Frame: baseline, over 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Number of Participants Discontinuing Due to Adverse Events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-Item and 5-Item [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Vital Signs - Weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Vital Signs - Pulse Rate [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Vital Signs - Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	215
Study Start Date:	December 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Placebo Comparator Placebo every day (QD), by mouth (PO) for 12 weeks	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408993

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.
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.
Wu Han, China, 430022
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.
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.
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.
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.
Changsha, China, 410011

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10599, F1J-MC-HMEQ(a)
Study First Received:	December 6, 2006
Results First Received:	February 5, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00408993 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Diabetic Neuropathies
Adrenergic Agents
Psychotropic Drugs
Diabetes Mellitus
Endocrine System Diseases
Pain
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Dopamine
Neuromuscular Diseases
Peripheral Nervous System Diseases
Dopamine Agents
Endocrinopathy
Antidepressive Agents
Diabetes Complications

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Diabetic Neuropathies
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Diabetes Mellitus
Endocrine System Diseases

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Serotonin Agents
Neuromuscular Diseases
Therapeutic Uses
Peripheral Nervous System Diseases
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents
Diabetes Complications

ClinicalTrials.gov processed this record on September 01, 2009