NCT00908375

Efficacy of Pregabalin in Patients With Radicular Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

Detailed description

Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.

Conditions

• Neuropathy; Radicular, Lumbar, Lumbosacral
• Failed Back Surgery Syndrome
• Spinal Stenosis
• Herniated Disc

Interventions

Type	Name	Description
DRUG	Pregabalin	One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
DRUG	Sugar Pill	One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2009-05-25
• Last updated: 2014-10-13
• Results posted: 2014-09-16

Locations

1 site across 1 country: United States