NCT01633086

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Neuropathic pain is a common symptom of diabetic neuropathy, and predominantly involves the lower limbs. Current strategies for the management of painful diabetic neuropathy include improved glycemic control, use of analgesics and addition of tricyclic antidepressants and anticonvulsants. However, many patients experience unsatisfactory responses and some undesired side effects. Considerable evidence implicates impaired nitric oxide synthesis plays an important role in the pathogenesis of diabetic neuropathic pain. Several small studies have shown that topical nitroglycerin ointment has local vasodilating properties, and a previous study has demonstrated that isosorbide dinitrate in spray form as a nitric oxide donor relieved some neuropathic symptoms in patients with painful diabetic neuropathy. Based on the findings, the investigators hypothesize that nitric oxide gel could be used as an alternative pain-relieving agent for patients with resistant diabetic neuropathic pain.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-07-04
• Last updated: 2015-03-12

Locations

1 site across 1 country: Taiwan