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Trial record 56 of 89 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

Tracking Information
First Submitted Date  ICMJE May 17, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01363284 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
Official Title  ICMJE Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients Based on Assessment of Endogenous Analgesia Capabilities
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Painful Neuropathy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Duloxetine
Publications * Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-8. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2011)
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01363284
Other Study ID Numbers  ICMJE diabetic_Duloxetine09CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party d_yarnitsky, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: David Yarnitsky, PhD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP