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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01588314 |
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Date of registration:
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26/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease
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Scientific title:
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Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01588314 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeanine R. Jarnes, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota, Fairview |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuropathic Pain
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Fabry Disease
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Intervention(s)
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Drug: Gabapentin
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Drug: placebo
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Primary Outcome(s)
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average reduction in hydrocodone-acetaminophen use
[Time Frame: assessed at the end of the study]
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Secondary Outcome(s)
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Pain levels
[Time Frame: assessed at the end of the study]
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Number and type of adverse events
[Time Frame: assessed at the end of the study]
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Define therapeutic level for gabapentin
[Time Frame: assessed at the end of the study]
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Secondary ID(s)
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1112M07943
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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