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

Overview

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.

Full Title of Study: “A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: duloxetine hydrochloride

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Overall Official(s)
    • 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

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