A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetes
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: clonidine hydrochloride topical gel, 0.1%
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: pain; diabetic neuropathy; pain in feet

Summary:

      Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of
      Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their
      12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this
      study and receive active study drug in an open-label manner.
    

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.