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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633086
• Other study ID #: DMR99-IRB-273
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2012
• Last updated: March 11, 2015
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2015
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• nitric oxide gel
st gel: sodium nitrites,BID local use X 28 days nd gel: maleic/ascorbic acids ,BID local use X 28 days
• placebo gel
placebo gel,BID local use X 28 days

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuopathic Pain Scale		12 weeks	No
Secondary	vascular duplex parameters		12 weeks	No
Secondary	the likelihood of reusing the nitric oxide gel recorded		12weeks	No