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Trial record 74 of 325 for:    clonidine

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

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ClinicalTrials.gov Identifier: NCT02355158
Recruitment Status : Completed
First Posted : February 4, 2015
Results First Posted : July 2, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Diabetes Drug: clonidine hydrochloride topical gel, 0.1% Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Clonidine hydrochloride topical gel, 0.1%
Drug: clonidine hydrochloride topical gel, 0.1%



Primary Outcome Measures :
  1. Summary of Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Month 12 or last visit ]
    The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, which contains a list of descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e., mechanical and thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items is quantified on an 11-point (0-10) numerical scale. NPSI total score was calculated and summarized descriptively at month 12 or the subjects last visit. The total score was calculated and summarized.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355158


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85023
United States, California
Santa Monica, California, United States, 90404
Walnut Creek, California, United States, 94598
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Bradenton, Florida, United States, 34205
Brandon, Florida, United States, 33511
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33143
Tampa, Florida, United States, 33606
West Palm Beach, Florida, United States, 33401
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Missouri
Hazelwood, Missouri, United States, 63042
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Texas
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
United States, Washington
Renton, Washington, United States, 98507
Sponsors and Collaborators
BioDelivery Sciences International
Investigators
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Principal Investigator: Aziz Shaibani, MD Nerve & Muscle Center of Texas

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Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT02355158     History of Changes
Other Study ID Numbers: CLO-311
First Posted: February 4, 2015    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017
Keywords provided by BioDelivery Sciences International:
pain
diabetic neuropathy
pain in feet
Additional relevant MeSH terms:
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Clonidine
Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action