a safety study of clonidine hydrochloride topical gel, 0.1% in the treatment of painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy; Diabetes

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.

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. all eligible subjects will receive clonidine gel regardless of the blinded treatment they have received in the previous double-blind study (clonidine gel or placebo gel). study drug will be applied topically tid to both feet for 12 months during an open-label treatment phase. approximately 400 adult subjects with pdn are estimated to enroll in this study.

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.

Keywords: pain diabetic neuropathy pain in feet