Clincosm LogoSign in Get a demo

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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00266643
Collaborator
(none)
205
Enrollment
20
Locations
16
Duration (Months)
10.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: duloxetine hydrochloride
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain
Study Start Date :
Dec 1, 2005
Actual Study Completion Date :
Apr 1, 2007

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • You have uncontrolled narrow angle glaucoma.

Contacts and Locations

Locations

Site City State Country Postal Code
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. Phoenix Arizona United States 85006
2 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
3 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
4 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
5 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
6 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
7 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
8 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
9 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
10 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
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00266643
Other Study ID Numbers:
  • 8952
  • F1J-US-HMDY
First Posted:
Dec 19, 2005
Last Update Posted:
Aug 3, 2007
Last Verified:
Aug 1, 2007
Additional relevant MeSH terms:
Diabetic Neuropathies
Duloxetine Hydrochloride

Study Results

No Results Posted as of Aug 3, 2007