Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: duloxetine hydrochloride

Primary Measures

• Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded.

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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 Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266643

Study ID Number: 8952

ClinicalTrials.gov Identifier: NCT00266643

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry