Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
China Medical University Hospital
Treatments:
Ascorbic Acid
Nitric Oxide
Criteria
Inclusion Criteria:

1. Subjects>=30 and<=80 years of age.

2. Subjects with type 1 or type 2 diabetes mellitus with painful diabetic neuropathy.

3. Subjects without undergoing treatment for painful diabetic neuropathy or with
treatment for at least 3 months but still presenting neuropathic pain prior to
randomization.

4. Subjects who are healthy without any serious diseases that require hospitalization
during the study period.

5. Subjects who are capable of understanding and having signed the Informed Consent Form
after detailed description of the treatment procedures and potential risks and
benefits.

Exclusion Criteria:

1. Subjects with diagnosis of cancer and are still on active therapies.

2. Subjects with diagnosis of an active disease (e.g. hyper-or-hypothyroidism, advanced
chronic renal failure, severe anemia, liver cirrhosis, active infectious disease etc.)
and are still under regular treatment for this disease

3. Subjects with peripheral neuropathy caused by a known acute or chronic disease or
injury

4. Subjects who are on other medications with pharmacological actions that may lead to
excessive formation of nitric oxide (e.g. sublingual nitroglycerin, sildanafil etc.)
or may accentuate drug effects due to excessive formation of nitric oxide.

5. Subjects with severe peripheral artery disease leading to absence of foot pulses.

6. Subjects with erratic glycemic control (HbA1c 12).

7. Subjects with an active foot ulceration or infection.

8. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.

9. Subjects who have been enrolled into any clinical study in the preceding 3 months
prior to randomization.

10. Subjects with current substance or alcohol abuse that in the opinion of the
investigator would interfere with compliance or with interpretation of the study
result

11. Female subject of childbearing potential who is lactating or has positive urine
pregnancy test at V0 or refuses to adop reliable method of contraception during the
study.