Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00266643
First received: December 15, 2005
Last updated: August 1, 2007
Last verified: August 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathy, Painful |
Drug: duloxetine hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome 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 Outcome 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
| Estimated Enrollment: | 205 |
| Study Start Date: | December 2005 |
| Study Completion Date: | April 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266643
Locations
| United States, Arizona | |
| 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. | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Florida | |
| 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. | |
| Ft. Myers, Florida, United States, 33912 | |
| 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. | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Hawaii | |
| 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. | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| 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. | |
| Chicago, Illinois, United States, 60610 | |
| 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. | |
| Springfield, Illinois, United States, 62704 | |
| United States, Iowa | |
| 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. | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| 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. | |
| Topeka, Kansas, United States, 66606 | |
| United States, Louisiana | |
| 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. | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Missouri | |
| 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. | |
| St Louis, Missouri, United States, 63141 | |
| 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. | |
| St. Peters, Missouri, United States, 63376 | |
| United States, North Carolina | |
| 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. | |
| Morehead City, North Carolina, United States, 28557 | |
| United States, Ohio | |
| 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. | |
| Dayton, Ohio, United States, 45439 | |
| United States, Oklahoma | |
| 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. | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Texas | |
| 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. | |
| Dallas, Texas, United States, 75231 | |
| 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 Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| 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. | |
| Ogden, Utah, United States, 84403 | |
| United States, West Virginia | |
| 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. | |
| Charleston, West Virginia, United States, 25304 | |
| Puerto Rico | |
| 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, 00716 | |
| 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, 00918 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00266643 History of Changes |
| Other Study ID Numbers: | 8952, F1J-US-HMDY |
| Study First Received: | December 15, 2005 |
| Last Updated: | August 1, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013