Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain

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. Identifier: NCT00266643
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : August 3, 2007
Information provided by:
Eli Lilly and Company

December 15, 2005
December 19, 2005
August 3, 2007
December 2005
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Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded.
Same as current
Complete list of historical versions of study NCT00266643 on Archive Site
  • Daily: 24 hr avg pain, worst pain, night pain; NSAID & acetaminophen use.
  • Weekly: Leeds Sleep Evaluation Questionnaire, Brief Profile of Mood States, Clinical Global Impression of Severity. Visits 2, 7, 11: Treatment Satisfaction Questionnaire for Medic
Same as current
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Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain
A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain
This study is to compare the tolerability of different methods for switching from another medication to duloxetine for the management of diabetic nerve pain. The primary objective is to compare the most gradual method with the most abrupt method, to see if they have different tolerability.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
Drug: duloxetine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2007
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Inclusion Criteria:

  • You must have been diagnosed with Diabetic Peripheral Neuropathic Pain.
  • You must have been taking the same dose of amitriptyline once daily at bedtime for at least four (4) weeks.
  • You must have stable glycemic control.
  • You must be able to visit the doctor's office once a week for ten (10) weeks.

Exclusion Criteria:

  • You are in the acute recovery phase following myocardial infarction.
  • You have Major Depressive Disorder, an Anxiety Disorder, or some other psychiatric illnesses that the doctor will ask you about.
  • You are allergic to amitriptyline or duloxetine.
  • You are currently taking an anticonvulsant, cisapride (Propulsid), or if you have taken an opioid for three or more consecutive days during the 14 days prior to Visit 2.
  • You have uncontrolled narrow angle glaucoma.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
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Eli Lilly and Company
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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
Eli Lilly and Company
August 2007

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