Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
|ClinicalTrials.gov Identifier: NCT01363284|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : October 11, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363284
|Rambam Medical center|
|Principal Investigator:||David Yarnitsky, PhD||Rambam Health Care Campus|