Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
1 other identifier
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 11, 2012
January 1, 2012
1 year
May 17, 2011
January 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (1)
Metanx®
Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily.
Interventions
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.
Eligibility Criteria
Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®
You may qualify if:
- New Metanx® Start
- Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pamlab, L.L.C.lead
- InfoMedics, Inc.collaborator
Study Sites (1)
Endocrinology Associates
Montgomery, Alabama, 36106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Trippe, M.D.
Endocrinology Associates
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2011
First Posted
June 8, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 11, 2012
Record last verified: 2012-01