Diabetes | Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
Diabetes research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DuloxetineFirst week of placebo. then, initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DuloxetineThe first week of the treatment is the placebo treatment. The effect of placebo will be taken into consideration for further evaluation the duloxetine effect on clinical pain and descending pain inhibition capabilities.
Start Date: June 2010
Completed Date: August 2012
Primary Outcome: Prediction of duloxetine pain relief efficacy by pre-treatment extent of the CPM response
Secondary Outcome: Treatment-related increase in CPM response
Study sponsors, principal investigator, and references
Principal Investigator: David Yarnitsky, PhD
Lead Sponsor: Rambam Health Care Campus
Collaborator: Eli Lilly and Company