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A Study for the Treatment of Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058968
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : May 17, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 15, 2003
First Posted Date  ICMJE April 16, 2003
Last Update Posted Date May 17, 2007
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2007)		 Reduction in average pain severity as measured by an 11-point Likert scale.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
  • Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
  • Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
  • Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
  • Brief Pain Inventory to measure the severity of pain.
  • Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
  • Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
  • Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for the Treatment of Painful Diabetic Neuropathy
Official Title  ICMJE Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
Brief Summary The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Detailed Description The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: Duloxetine hydrochloride
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9. doi: 10.2337/dc06-2009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		 660
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female outpatients at least 18 years of age.
  • Patients with pain due to diabetic neuropathy in both legs.
  • Females must not be pregnant or plan to become pregnant during the study.
  • Stable Glycemic control.
  • Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.

Exclusion Criteria:

  • You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
  • You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
  • You have participated in a study for an investigational drug within the last 30 days.
  • You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
  • You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada,   Croatia,   Germany,   Hungary,   Poland,   Puerto Rico,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT00058968
Other Study ID Numbers  ICMJE 4097
F1J-MC-HMAV
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP