Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00322621

Purpose

To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: Duloxetine	Phase IV

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Brief Pain Inventory 24-hour average pain item score, maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain, who achieve 30% pain reduction at 8 weeks [ Time Frame: over 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BPI 24-hour average pain item, percentage of patients with a ≥50% reduction from Visit 2 [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: No ]
BPI severity and interference item scores [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: No ]
Patient's Global Impressions of Improvement [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: No ]
Clinical Global Impressions of Severity [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: No ]
Sensory portion of the Short-Form McGill Pain Questionnaire [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 8 weeks and 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	217
Study Start Date:	April 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental All subjects receive 30 mg QD, PO for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months	Drug: Duloxetine

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:

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, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be 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 with 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: NCT00322621

Locations

Brazil
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.
Fortaleza, Brazil, 60120-020
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.
Porto Alegre, Brazil, 90035170
France
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Angers, France, 49033
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Bron, France, 69500
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Annecy, France, 74011
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Narbonne, France, 11108
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Nevers, France, 58000
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Nice, France, 06002
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Dijon, France, 21079
Germany
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Chemitz, Germany, 09111
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Dresden, Germany, 01307
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Mainz, Germany, D-55116
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Münster, Germany, 48145
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Schkeuditz, Germany, 04435
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Siegen, Germany, 57072
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Wurzburg, Germany, 97070
Italy
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Genova, Italy, 16132
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Perugia, Italy, 06100
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Rome, Italy, 00161

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10258, F1J-MC-HMEM
Study First Received:	May 5, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00322621
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 January 14, 2009