Neuropathic Pain Clinical Trial
Official title:
Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease
NCT number | NCT01588314 |
Other study ID # | 1112M07943 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | June 2014 |
Verified date | May 2019 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in patients' use of hydrocodone-acetaminophen.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - diagnosis of Fabry Disease - age = 18 years of age at study enrollment - current neuropathic pain at any severity level Exclusion Criteria: - known sensitivity or allergy to study drug - history of illicit drug use - pregnancy - suicidal thoughts at study enrollment as assess by the C-SSRS |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota, Fariview | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Genzyme, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | average reduction in hydrocodone-acetaminophen use | assessed at the end of the study | ||
Secondary | Number and type of adverse events | assessed at the end of the study | ||
Secondary | Pain levels | assessed at the end of the study | ||
Secondary | Define therapeutic level for gabapentin | assessed at the end of the study |
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