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

NCT01633086 | Completed Phase 2

• 1 other identifier: DMR99-IRB-273
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neuopathic Pain Scale

  12 weeks

Secondary Outcomes (2)

• vascular duplex parameters

  12 weeks

• the likelihood of reusing the nitric oxide gel recorded

  12weeks

Study Arms (2)

nitric oxide gel

ACTIVE COMPARATOR

1. st gel: sodium nitrites 2. nd gel: maleic/ascorbic acids

Drug: nitric oxide gel

Placebo gel

PLACEBO COMPARATOR

1. st gel: phosphate-buffered saline 2. nd gel: maleic/ascorbic acids

Drug: placebo gel

Interventions

nitric oxide gel DRUG

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

nitric oxide gel

placebo gel DRUG

placebo gel,BID local use X 28 days

Placebo gel

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects\>=30 and\<=80 years of age.
• Subjects with type 1 or type 2 diabetes mellitus with painful diabetic neuropathy.
• Subjects without undergoing treatment for painful diabetic neuropathy or with treatment for at least 3 months but still presenting neuropathic pain prior to randomization.
• Subjects who are healthy without any serious diseases that require hospitalization during the study period.
• 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.

You may not qualify if:

• Subjects with diagnosis of cancer and are still on active therapies.
• 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
• Subjects with peripheral neuropathy caused by a known acute or chronic disease or injury
• 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.
• Subjects with severe peripheral artery disease leading to absence of foot pulses.
• Subjects with erratic glycemic control (HbA1c 12).
• Subjects with an active foot ulceration or infection.
• Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
• Subjects who have been enrolled into any clinical study in the preceding 3 months prior to randomization.
• 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
• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ching-Chu Chen, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Ching-Chu Chen, M.D

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: July 4, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

TW (1)