Effect of Milnacipran in Chronic Neuropathic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01225068|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : September 25, 2013
Last Update Posted : January 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Milnacipran Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||April 2012|
milnacipran 50 mg bid; can be increased to 100 mg bid
Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
Other Name: Savella
Placebo Comparator: Placebo
2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
- Effect Size of VAS Pain [ Time Frame: 6 weeks from baseline ]
Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation.
This is the primary outcome measure.
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 ClinicalTrials.gov identifier (NCT number): NCT01225068
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Thomas J Schnitzer, MD, PhD||Northwestern University|