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A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy

Information source: BioDelivery Sciences International
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Painful Diabetic Neuropathy; Diabetes

Intervention: clonidine hydrochloride topical gel, 0.1% (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: BioDelivery Sciences International

Official(s) and/or principal investigator(s):
Aziz Shaibani, MD, Principal Investigator, Affiliation: Nerve & Muscle Center of Texas

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.

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Over-all adverse events

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Phoenix, Arizona 85023, United States

Santa Monica, California 90404, United States

Walnut Creek, California 94598, United States

Waterbury, Connecticut 06708, United States

Bradenton, Florida 34205, United States

Brandon, Florida 33511, United States

Jupiter, Florida 33458, United States

Miami, Florida 33143, United States

Tampa, Florida 33606, United States

West Palm Beach, Florida 33401, United States

Columbus, Georgia 31904, United States

Kansas City, Kansas 66160, United States

Hazelwood, Missouri 63042, United States

Winston-Salem, North Carolina 27103, United States

Warwick, Rhode Island 02886, United States

Dallas, Texas 75230, United States

Houston, Texas 77030, United States

Houston, Texas 77074, United States

San Antonio, Texas 78229, United States

Renton, Washington 98507, United States

Additional Information

Starting date: June 2014
Last updated: January 30, 2015

Page last updated: August 20, 2015

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