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

January 9, 2012 updated by: Pamlab, L.L.C.
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Endocrinology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metanx®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 6 and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 6 and Week 12
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
Baseline, Week 6 and Week 12
To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale
Time Frame: Baseline, Week 6 and Week 12
Baseline, Week 6 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamlab, L.L.C.

Collaborators

InfoMedics, Inc.

Investigators

  • Principal Investigator: Bruce Trippe, M.D., Endocrinology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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