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

Phase 4

Completed

• Conditions: Diabetic Neuropathy, Painful

• Registration Number: NCT00266643
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Study First Posted: 2005-12-19
• Study Completion: 2007-04
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-01
• Last Update Posted: 2007-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇵🇷 San Juan, Puerto Rico