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

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

MedlinePlus related topics:

Diabetic Nerve Problems

Drug Information available for:

Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Brief Pain Inventory 24-hour average pain score (efficacy of duloxetine 60 to 120 mg QD) [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BPI worst pain, least pain, and current pain severity and average of 7 interference scores [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Improvement [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
EuroQoL Questionnaire - 5 dimensions [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
Tolerability of morning versus evening dosing, spontaneously reports adverse events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
Athens Insomnia Scale 8-item and 5-item [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
Laboratory measures [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	214
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 QD (morning or evening), 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 QD, 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:

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10599, F1J-MC-HMEQ(a)
First Received:	December 6, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00408993
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Dopamine

Neuromuscular Diseases

Diabetic Neuropathies

Peripheral Nervous System Diseases

Diabetes Mellitus

Endocrine System Diseases

Pain

Endocrinopathy

Serotonin

Duloxetine

Diabetes Complications

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 22, 2008

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