Status:
COMPLETED
Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
Lead Sponsor:
Pamlab, L.L.C.
Collaborating Sponsors:
HealthCore, Inc.
Conditions:
Diabetic Peripheral Neuropathy (DPN)
Eligibility:
All Genders
25-80 years
Brief Summary
This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity...
Detailed Description
The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI ...
Eligibility Criteria
Inclusion
- Patients must have pharmacy claims for \>120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.
- Patients must have a diagnosis of diabetes prior to or including the index date.
- Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.
- Patients must have a diagnosis of lower limb ulcer.
Exclusion
- Patients will be excluded if they have \<18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.
- Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with \>1mg folic acid.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01247558
Start Date
November 1 2010
End Date
September 1 2011
Last Update
July 25 2012
Active Locations (1)
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1
HealthCore, Inc.
Wilmington, Delaware, United States, 19801