- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633086
A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
March 11, 2015 updated by: China Medical University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taichung, Taiwan, 404
- China Medical University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: nitric oxide gel
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Placebo Comparator: Placebo gel
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placebo gel,BID local use X 28 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuopathic Pain Scale
Time Frame: 12 weeks
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
vascular duplex parameters
Time Frame: 12 weeks
|
12 weeks
|
the likelihood of reusing the nitric oxide gel recorded
Time Frame: 12weeks
|
12weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ching-Chu Chen, M.D., China Medical University Hospital
- Study Director: Ching-Chu Chen, M.D, China Medical University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
May 30, 2012
First Submitted That Met QC Criteria
June 29, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
March 12, 2015
Last Update Submitted That Met QC Criteria
March 11, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- DMR99-IRB-273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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