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A Long-Term Study for the Treatment of Painful Diabetic Neuropathy

This study is currently recruiting participants.
Verified by Eli Lilly and Company, April 2008

Sponsors and Collaborators: Eli Lilly and Company
Shionogi
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00641719
  Purpose

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.


Condition Intervention Phase
Diabetic Neuropathies
 Drug: Duloxetine hydrochloride
 Phase III

MedlinePlus related topics:   Diabetic Nerve Problems   

ChemIDplus related topics:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Brief Pain Inventory to measure the severity of pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) total score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:   300
Study Start Date:   March 2008
Estimated Study Completion Date:   February 2010
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Duloxetine 40 mg QD, PO, 1 year
Drug: Duloxetine hydrochloride
Duloxetine 40 mg QD, PO, 1 year
B: Experimental
Duloxetine 60 mg QD, PO, 1 year
Drug: Duloxetine hydrochloride
Duloxetine 60 mg QD, PO, 1 year

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Outpatients who have completed the 13-week treatment in the preceding study (Protocol No.0715N0831).
  • Patients who desire to receive continued treatment with LY248686 from the preceding study.
  • Patients with latest HbA1c ≤9.0% before Visit 7.
  • Patients who can provide written consent in person.

Exclusion Criteria:

  • Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
  • Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
  • Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641719

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559    

Locations
Japan
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.     Not yet recruiting
      Hokkaido, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Aomori, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Miyagi, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Fukushima, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Ibaragi, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Tochigi, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Gunma, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Saitama, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Chiba, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Tokyo, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Kanagawa, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Niigata, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Kagoshima, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Toyama, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Sizuoka, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Aichi, Japan
      Contact: Eli Lilly            
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.     Recruiting
      Kyoto, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Osaka, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Hyogo, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Okayama, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Hiroshima, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Tokushima, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Fukuoka, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Oita, Japan
      Contact: Eli Lilly            
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.     Not yet recruiting
      Fukui, Japan
      Contact: Eli Lilly            

Sponsors and Collaborators
Eli Lilly and Company
Shionogi

Investigators
Study Director:     Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM 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:   12194, F1J-JE-HMFY
First Received:   March 19, 2008
Last Updated:   April 21, 2008
ClinicalTrials.gov Identifier:   NCT00641719
Health Authority:   Japan: Ministry of Health, Labor and Welfare

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 17, 2008

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