Effect of Milnacipran in Chronic Neuropathic Low Back Pain
|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.
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|