Clinical trial NCT02355158: A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Long-term Use of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Diabetes
Keywords: pain
diabetic neuropathy
pain in feet
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Summary of Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Month 12 or last visit
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Santa Monica
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Kansas City
country: United States
state: Kansas
city: Hazelwood
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Warwick
country: United States
state: Rhode Island
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Renton
country: United States
state: Washington
Study officials:
affiliation: Nerve & Muscle Center of Texas
name: Aziz Shaibani, MD
role: PRINCIPAL_INVESTIGATOR
References: