Effect of Milnacipran in Chronic Neuropathic Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
Forest Laboratories
Rehabilitation Institute of Chicago
Best Practice
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01225068
First received: October 13, 2010
Last updated: December 5, 2013
Last verified: December 2013
Results First Received: April 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: Milnacipran
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Outpatient clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening visit prior to randomization

Reporting Groups
  Description
Milnacipran Milnacipran : 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.
Placebo Placebo treatment group

Participant Flow:   Overall Study
    Milnacipran     Placebo  
STARTED     20     20  
COMPLETED     16     19  
NOT COMPLETED     4     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Milnacipran Milnacipran : 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.
Placebo Placebo treatment group
Total Total of all reporting groups

Baseline Measures
    Milnacipran     Placebo     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.1  ± 11.6     48.3  ± 9.1     47.7  ± 10.3  
Gender  
[units: participants]
     
Female     10     11     21  
Male     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures

1.  Primary:   Effect Size of VAS Pain   [ Time Frame: 6 weeks from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas J Schnitzer
Organization: Northwestern University Feinberg School of Medicine
phone: 3125032315
e-mail: tjs@northwestern.edu


No publications provided


Responsible Party: Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier: NCT01225068     History of Changes
Other Study ID Numbers: STU00036897
Study First Received: October 13, 2010
Results First Received: April 17, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board