Back to resultsA Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
nitric oxide gel
placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
nitric oxide gel
Placebo gel
Arm Description
st gel: sodium nitrites nd gel: maleic/ascorbic acids
st gel: phosphate-buffered saline nd gel: maleic/ascorbic acids
Outcomes
Primary Outcome Measures
Neuopathic Pain Scale
Secondary Outcome Measures
vascular duplex parameters
the likelihood of reusing the nitric oxide gel recorded
Full Information
NCT ID
NCT01633086
First Posted
May 30, 2012
Last Updated
March 11, 2015
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01633086
Brief Title
A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Official Title
A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitric oxide gel
Arm Type
Active Comparator
Arm Description
st gel: sodium nitrites
nd gel: maleic/ascorbic acids
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Arm Description
st gel: phosphate-buffered saline
nd gel: maleic/ascorbic acids
Intervention Type
Drug
Intervention Name(s)
nitric oxide gel
Intervention Description
st gel: sodium nitrites,BID local use X 28 days
nd gel: maleic/ascorbic acids ,BID local use X 28 days
Intervention Type
Drug
Intervention Name(s)
placebo gel
Intervention Description
placebo gel,BID local use X 28 days
Primary Outcome Measure Information:
Title
Neuopathic Pain Scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
vascular duplex parameters
Time Frame
12 weeks
Title
the likelihood of reusing the nitric oxide gel recorded
Time Frame
12weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Chu Chen, M.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ching-Chu Chen, M.D
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
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A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
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