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NCT01247558 · ClinicalTrials.gov registry record
Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
A clinical trial of Diabetic Peripheral Neuropathy (DPN), sponsored by Pamlab, L.L.C..
- Completed
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT01247558: Completed study of Diabetic Peripheral Neuropathy (DPN), sponsored by Pamlab, L.L.C..
NCT01247558 is a study of Diabetic Peripheral Neuropathy (DPN) that has completed, run by Pamlab, L.L.C.. The registered enrollment target is 500 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01247558, a study of Diabetic Peripheral Neuropathy (DPN), has completed, sponsored by Pamlab, L.L.C..
- COMPLETED
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Total healthcare utilization and costs for patients treated with Metanx® will be compared to total healthcare utilization and costs for control patients who did not receive Metanx®. Cost data will be presented as Mean (SD) and median.
Conditions Studied
Interventions
- OTHER Metanx® (a medical food)
- OTHER Not treated with Metanx®
Study Locations (1)
Delaware
- HealthCore, Inc. - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-09 |
What the finished NCT01247558 record still lists
NCT01247558 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Diabetic Peripheral Neuropathy (DPN) appearing as the primary indexed condition, and to 2 interventions - of which Metanx® (a medical food) is the first listed.
NCT01247558 reports a single indexed study location in Delaware.
Frequently Asked Questions
What is clinical trial NCT01247558 about?
NCT01247558 is a clinical study titled "Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy". 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 da...
What is the current status of trial NCT01247558?
This trial is currently completed. The enrollment target is 500 participants. The study started on 2010-11. Estimated completion is 2011-09.
What conditions does trial NCT01247558 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy (DPN).
What interventions are being tested in trial NCT01247558?
The interventions under investigation include: Metanx® (a medical food) (OTHER), Not treated with Metanx® (OTHER).
Who is sponsoring clinical trial NCT01247558?
This trial is sponsored by Pamlab, L.L.C., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01247558 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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