Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify, prior to prescribing, which neuropathic pain patients will benefit from duloxetine more specific the investigators aims are to:

• Verify whether presence of chronic pain alters the pain modulation mechanisms, such as DNIC (diffuse noxious inhibitory control) and TS (temporal summation).

• Investigate whether anti-neuropathic medications such as duloxetine indeed change the pain modulation profile, and whether this profile change is associated with a reduction of clinical pain.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Patients diagnosed as having painful diabetic neuropathy.

• Pain is experienced for more than 3 months.

• Pain severity is ≥ 4 on a 0-10 scale (last month average).

Exclusion Criteria:

• Patient already receiving duloxetine or another SNRI/SSRI.

• Known hypersensitivity to duloxetine or any of the inactive ingredients.

• Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.

• Uncontrolled narrow-angle glaucoma

• Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine (Mellaril), Cymbalta and thioridazine should not be co-administered

• Inability to perform psychophysical testing, due to language or perceptual barriers.