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Completed

NCT Number: NCT00266643

Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve 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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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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., Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duloxetine hydrochloride

Drug

Primary outcomes

  1. 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 outcomes

  1. Daily: 24 hr avg pain, worst pain, night pain; NSAID & acetaminophen use.

  2. Weekly: Leeds Sleep Evaluation Questionnaire, Brief Profile of Mood States, Clinical Global Impression of Severity. Visits 2, 7, 11: Treatment Satisfaction Questionnaire for Medic

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain

Important dates

Study start
2005
Study completion
2007
First posted
Dec 19, 2005
Registry last updated
Aug 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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