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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier:
NCT01368549
First received: May 17, 2011
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Peripheral Neuropathy
 Other: Metanx® (a medical food)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
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)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368549

Locations
United States, Alabama
Endocrinology Associates
Montgomery, Alabama, United States, 36106
Sponsors and Collaborators
Pamlab, L.L.C.
InfoMedics, Inc.
Investigators
Principal Investigator: Bruce Trippe, M.D. Endocrinology Associates
  More Information

No publications provided

Responsible Party: Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier: NCT01368549     History of Changes
Other Study ID Numbers: M-005
Study First Received: May 17, 2011
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
Metanx
diabetes
neuropathy
folic acid
folate
L-methylfolate
 vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin
DPN

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Pyridoxal Phosphate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013