Diabetic Neuropathy, Painful
Conditions
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.
Interventions
DRUGduloxetine hydrochloride
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 2. * You have uncontrolled narrow angle glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Puerto Rico, United States
Outcome results
None listed