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

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ClinicalTrials.gov Identifier: NCT01368549
Recruitment Status : Unknown
Verified January 2012 by Pamlab, Inc. ( Pamlab, L.L.C. ).
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2011
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetic Peripheral Neuropathy Other: Metanx® (a medical food)

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 Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Mecobalamin
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale [ Time Frame: Baseline, Week 6 and Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pamlab, L.L.C.
ClinicalTrials.gov Identifier: NCT01368549     History of Changes
Other Study ID Numbers: M-005
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Pamlab, Inc. ( Pamlab, L.L.C. ):
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
Vitamins
Vitamin B 12
Vitamin B 6
Pyridoxal Phosphate
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs