Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02355158
Eligibility Criteria:
Inclusion Criteria:
* The subject has provided written informed consent.
* The subject has Type 1 or Type 2 diabetes mellitus with glycemic control that has been optimized on diet therapy, oral anti-hyperglycemic agents and/or insulin.
* The subject must be a male or non-pregnant, non-lactating female. Females must be practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥12 months). Non-pregnancy will be confirmed (as applicable) by a pregnancy test conducted at the Entry Visit. Double-barrier methods, hormonal contraceptives, and abstinence are acceptable birth control methods for this study.
* The subject has completed their 12-week participation according to the protocol in the previously conducted double-blind study, CLO-290.
* The subject is medically stable at the end-of-study visit (Day 85) of Study CLO-290, and in the opinion of the Investigator, is in otherwise good general health based on physical examination, ECG, and laboratory evaluation.
* Subject has the capabilities of applying topical gel to both feet TID. A caregiver, trained by the study staff to apply study medication, would be a suitable alternative to self-application of the treatment.
Exclusion Criteria:
* The subject is using an implanted medical device (e.g., spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain.
* The subject is clinically hypotensive with a resting diastolic blood pressure \<60 mmHg or a systolic blood pressure \<90 mmHg.
* The subject has recent history (within the past 3 months) or current symptoms of orthostatic hypotension with a sudden fall in blood pressure on standing accompanied by dizziness and lightheadedness.
* The subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study.
* The subject has a history of substance abuse disorder as defined by DSM-IV-TR within the past 6 months, has current evidence for substance abuse disorder, or is receiving medicinal treatment for drug abuse.
* The subject has symptomatic or severe coronary insufficiency, clinically significant cardiac conduction disturbances, myocardial infarction (within last 6 months), cerebrovascular disease, or chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
* The subject is likely to be noncompliant or unreliable in providing ratings as judged by the Investigator.
* The subject has evidence of clinically significant peripheral vascular disease as evidenced by a history of intermittent claudication or evidence of vascular ulcers, including venous stasis ulcers.
* The subject is currently taking or has taken clonidine in any form other than Clonidine Gel study drug (i.e., oral, transdermal patch) over the past 4 months.
* The subject has developed hypersensitivity or intolerance to clonidine.
* The subject is currently receiving any non-oral treatment that could affect neuropathic pain.
* Subject has a history of malignancy within the past 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
* The subject has clinical evidence of pedal edema or venous stasis disease associated with significant skin changes on physical examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02355158
Study Brief:
Protocol Section:
NCT02355158