CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Mannitol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02728687
NCT02728687Phase 2Completed
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A Double Blind, Randomized Crossover Study of Efficacy and Safety of Topical Menthol, With and Without Mannitol, in the Treatment of Painful Diabetic Peripheral Neuropathy

University of British Columbia·interventional·Posted Apr 5, 2016·Updated Mar 2, 2021

In Brief

A Phase 2 clinical trial evaluating Mannitol and Menthol for Diabetic Peripheral Neuropathy. Completed, enrolled 72 participants across 5 sites.

Detailed Summary

Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have multiple side effects. To find out if a menthol cream alone or with added mannitol treats PDPN effectively, 90 participants with PDPN, after one month of observation, will receive randomly assigned menthol cream or the same cream with mannitol added for 3 months with a crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and interference scores, DN4 scores, cream % effectiveness and side effects will be compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartMar 15, 2017
Primary CompletionMar 30, 2020
Study CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.2 years ago

Interventions

Mannitoldrug

Apply cream as needed up to 4 times daily to the painful foot and leg

Mentholdrug

Apply cream as needed up to 4 times daily to the painful foot and leg