Clinical trial NCT01368549: Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
Official title: Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Peripheral Neuropathy
Keywords: Metanx
diabetes
neuropathy
folic acid
folate
L-methylfolate
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin
DPN
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: InfoMedics, Inc.
First posted: 2011-06-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®

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.

Eligibility 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).

Primary outcomes:
measure: To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
timeFrame: Baseline, Week 6 and Week 12
Secondary outcomes:
measure: To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS)
timeFrame: Baseline, Week 6 and Week 12
measure: To determine if Metanx® affects a subject's "quality of life" as determined by a symptom impact module.
timeFrame: Baseline, Week 6 and Week 12
measure: To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale
timeFrame: Baseline, Week 6 and Week 12
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Endocrinology Associates
state: Alabama
Study officials:
affiliation: Endocrinology Associates
name: Bruce Trippe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: