Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Sponsor: National Center for Research Resources (NCRR)
This PHASE3 trial investigates Diabetic Neuropathies and Pain and is currently completed. National Center for Research Resources (NCRR) leads this study, which shows 5 recorded versions since 1993 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.
The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.
The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Mar 1993
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Center for Research Resources (NCRR)
- University of Tennessee
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.