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Trial record 56 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01363284
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : October 11, 2017
Eli Lilly and Company
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Painful Neuropathy Drug: Duloxetine Not Applicable

Detailed Description:
There is no accepted practice for selecting among recommended medications for the individual neuropathic pain patient. Guidelines published to date provided the evidence for their efficacy, however, data is not available on how to choose the right medication for the right patient in order to avoid long 'trial and error's. We hypothesize that medications affecting specific process of pain modulation will be more efficacious in patients expressing dysfunction of that specific process. Therefore, medications that enhance descending inhibition such as SSNRI will be more efficacious in patients with less-efficient pain inhibition. The latter is assessed by the conditioned pain modulation (CPM) paradigm. Accordingly, the aim of this study is to examine this hypothesis in painful diabetic neuropathy patients, using duloxetine, an SSNRI agent assumed to augment descending pain inhibition by reuptake inhibition of noradrenalin and serotonin in the spinal cord dorsal horn synapses. We expect to find better effect of duloxetine in those patients whose pain inhibition capability is less efficient, as expressed by their baseline CPM. Further, we aim to evaluate whether pro-nocieptive pattern of pain modulation indeed reverses in response to treatment. This will be explored by comparing the CPM responses before and after treatment, and by correlating pain alleviation with the possible changes in CPM.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients Based on Assessment of Endogenous Analgesia Capabilities
Actual Study Start Date : June 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Duloxetine
The 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.
Drug: Duloxetine
First 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
Other Name: SSNRI

Primary Outcome Measures :
  1. Prediction of duloxetine pain relief efficacy by pre-treatment extent of the CPM response [ Time Frame: 2 year ]
    Regression model will assess predictive value of baseline pre-treatment extent of the CPM response and pain relief efficacy of duloxetine treatment.

Secondary Outcome Measures :
  1. Treatment-related increase in CPM response [ Time Frame: 2 years ]
    We propose that treatment-related increase in CPM response will be correlated with duloxetine pain relief efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01363284

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Rambam Medical center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Eli Lilly and Company
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Principal Investigator: David Yarnitsky, PhD Rambam Health Care Campus

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus Identifier: NCT01363284     History of Changes
Other Study ID Numbers: diabetic_Duloxetine09CTIL
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents