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

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: Metanx® (a medical food)

• Registration Number: NCT01368549
• Lead Sponsor: Pamlab, L.L.C.

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• New Metanx® Start
• Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.

Exclusion Criteria

• Patients who do not meet ADA criteria for DPN diagnosis.
• If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s).
• For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metanx®	Metanx® (a medical food)	Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily.

Primary Outcome Measures

Name	Time	Method
To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)	Baseline, Week 6 and Week 12

Secondary Outcome Measures

Name	Time	Method
To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS)	Baseline, Week 6 and Week 12
To determine if Metanx® affects a subject's "quality of life" as determined by a symptom impact module.	Baseline, Week 6 and Week 12
To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale	Baseline, Week 6 and Week 12

Trial Locations

Locations (1)

Endocrinology Associates; 🇺🇸 Montgomery, Alabama, United States