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A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy

NCT01633086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-03-12

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in symptom relief of subjects with painful diabetic neuropathy.

Conditions

  • Neuropathic Pain

Interventions

DRUG

nitric oxide gel

1. st gel: sodium nitrites,BID local use X 28 days 2. nd gel: maleic/ascorbic acids ,BID local use X 28 days

DRUG

placebo gel

placebo gel,BID local use X 28 days

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Ching-Chu Chen, M.D. · China Medical University Hospital

  • Ching-Chu Chen, M.D · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633086 on ClinicalTrials.gov