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NCT00726713 · ClinicalTrials.gov registry record · Phase 4
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
A Phase 4 study, sponsored by Pamlab.
- Completed
- Registry status
- Phase 4
- Development phase
- 214
- Enrollment target
NCT00726713: Completed Phase 4 study, sponsored by Pamlab.
NCT00726713 is a Phase 4 study that has completed, run by Pamlab. The registered enrollment target is 214 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00726713, a Phase 4 study, has completed, sponsored by Pamlab.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 214 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be randomly assigned to receive either Metanx or placebo for 6 months.
Primary Outcome
Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.
Interventions
- OTHER Metanx (a medical food)
- OTHER Metanx placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT00726713 record still lists
NCT00726713 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Metanx (a medical food) is the first listed.
NCT00726713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00726713 about?
NCT00726713 is a clinical study titled "Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)". The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of...
What is the current status of trial NCT00726713?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 214 participants. The study started on 2008-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00726713?
The interventions under investigation include: Metanx (a medical food) (OTHER), Metanx placebo (OTHER).
Who is sponsoring clinical trial NCT00726713?
This trial is sponsored by Pamlab, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00726713's enrollment target sits among peer trials
214 394th of 2000 higher than 1,605 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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