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

Primary Purpose

Painful Diabetic Neuropathy, Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
clonidine hydrochloride topical gel, 0.1%
Sponsored by
BioDelivery Sciences International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring pain, diabetic neuropathy, pain in feet

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Clonidine hydrochloride topical gel, 0.1%

Outcomes

Primary Outcome Measures

Summary of Neuropathic Pain Symptom Inventory (NPSI)
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.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2014
Last Updated
August 23, 2017
Sponsor
BioDelivery Sciences International
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1. Study Identification

Unique Protocol Identification Number
NCT02355158
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy, Diabetes
Keywords
pain, diabetic neuropathy, pain in feet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Clonidine hydrochloride topical gel, 0.1%
Intervention Type
Drug
Intervention Name(s)
clonidine hydrochloride topical gel, 0.1%
Primary Outcome Measure Information:
Title
Summary of Neuropathic Pain Symptom Inventory (NPSI)
Description
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.
Time Frame
Month 12 or last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Shaibani, MD
Organizational Affiliation
Nerve & Muscle Center of Texas
Official's Role
Principal Investigator
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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