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Effect of Milnacipran in Chronic Neuropathic Low Back Pain

NCT01225068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-01-17

Study results available
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Summary

Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

Conditions

  • Low Back Pain

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Shirley Ryan AbilityLab

    collaborator OTHER

  • Best Practice

    collaborator UNKNOWN

  • Northwestern University

    lead OTHER

Principal Investigators

  • Thomas J Schnitzer, MD, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225068 on ClinicalTrials.gov