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Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

NCT01247558 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2012-07-25

No results posted yet for this study

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 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.

Conditions

  • Diabetic Peripheral Neuropathy (DPN)

Interventions

OTHER

Metanx® (a medical food)

Patient cohort compliant on Metanx® BID therapy for \>120 days

OTHER

Not treated with Metanx®

Non-treated comparative cohort

Sponsors & Collaborators

  • HealthCore, Inc.

    collaborator INDUSTRY

  • Pamlab, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Ron Wade, RPh, MS · HealthCore, Inc.

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247558 on ClinicalTrials.gov