Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)|
- To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
- To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
- To determine if Metanx® affects a subject's "quality of life" as determined by a symptom impact module. [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
- To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily.
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.
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.
|United States, Alabama|
|Montgomery, Alabama, United States, 36106|
|Principal Investigator:||Bruce Trippe, M.D.||Endocrinology Associates|