Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Completed

Conditions studied: Diabetic Peripheral Neuropathy (DPN)

In brief

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 score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

Key facts

Study ID

NCT01247558

Run by

Pamlab, L.L.C.

People needed

500

Starts

2010-11-01

Expected to finish

2011-09-01

Last updated by the study team

2012-07-25

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HealthCore, Inc. — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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