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

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: December 15, 2005
Last updated: August 1, 2007
Last verified: August 2007

December 15, 2005
August 1, 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-Blind
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.
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
United States,   Puerto Rico
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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