NCT01368549

Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Pamlab, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will be an observational study in which patients who have been prescribed Metanx® are invited to participate in surveys regarding their experiences with Metanx®. The purpose of this study is to increase the understanding of the role of Metanx® in managing diabetic neuropathy, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for diabetic neuropathy.

Detailed description

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Metanx® (a medical food)	Metanx® is an orally-administered medical food, and each tablet contains 3mg of L-methylfolate, 35mg of Pyridoxal-5'-phosphate, and 2 mg of Methylcobalamin- which are the biologically active and immediately bioavailable forms of folate, vitamin B6, and vitamin B12, respectively. Dosage will be 1 tablet BID.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-06-08
• Last updated: 2012-01-11

Locations

1 site across 1 country: United States