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Trial record 74 of 326 for:    clonidine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Painful Diabetic Neuropathy
Diabetes
Intervention Drug: clonidine hydrochloride topical gel, 0.1%
Enrollment 197
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active
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Clonidine hydrochloride topical gel, 0.1%

clonidine hydrochloride topical gel, 0.1%

Period Title: Overall Study
Started 197
Completed 47
Not Completed 150
Arm/Group Title Active
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Clonidine hydrochloride topical gel, 0.1%

clonidine hydrochloride topical gel, 0.1%

Overall Number of Baseline Participants 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 197 participants
61.1  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants
Female
89
  45.2%
Male
108
  54.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants
Hispanic or Latino
40
  20.3%
Not Hispanic or Latino
157
  79.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
47
  23.9%
White
146
  74.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 197 participants
197
1.Primary Outcome
Title Summary of Neuropathic Pain Symptom Inventory (NPSI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
While 197 subjects received study drug, 172 completed the NPSI at the week 12 visit or at their last visit.
Arm/Group Title Active
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Clonidine hydrochloride topical gel, 0.1%

clonidine hydrochloride topical gel, 0.1%

Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.44  (25.13)
Time Frame 1 year 7 days
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
 
Arm/Group Title Active
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Clonidine hydrochloride topical gel, 0.1%

clonidine hydrochloride topical gel, 0.1%

All-Cause Mortality
Active
Affected / at Risk (%)
Total   1/197 (0.51%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active
Affected / at Risk (%) # Events
Total   23/197 (11.68%)    
Cardiac disorders   
Cardiac failure congestive  1  2/197 (1.02%)  2
Myodcaridal infarction  1  2/197 (1.02%)  2
Atrial fibrillation  1  1/197 (0.51%)  1
Coronary artery occlusion  1  1/197 (0.51%)  1
Tachyarrhythmia  1  1/197 (0.51%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/197 (0.51%)  1
Small intestinal obstruction  1  1/197 (0.51%)  1
Vomiting  1  1/197 (0.51%)  1
General disorders   
Death  1  1/197 (0.51%)  1
Non-cardiac chest pain  1  1/197 (0.51%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  1/197 (0.51%)  1
Infections and infestations   
Osteomyelitis  1  1/197 (0.51%)  1
Pneumonia  1  1/197 (0.51%)  1
Staphylococcal abscess  1  1/197 (0.51%)  1
Upper respiratory tract infection  1  1/197 (0.51%)  1
Injury, poisoning and procedural complications   
Concussion  1  1/197 (0.51%)  1
Metabolism and nutrition disorders   
Obesity  1  1/197 (0.51%)  1
Musculoskeletal and connective tissue disorders   
Costochondritis  1  1/197 (0.51%)  1
Spinal osteoarthritis  1  1/197 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Chronic lymphocytic leukaemia  1  1/197 (0.51%)  1
Skin cancer  1  1/197 (0.51%)  1
Psychiatric disorders   
Psychotic disorder  1  1/197 (0.51%)  1
Vascular disorders   
Ischaemic limb pain  1  1/197 (0.51%)  1
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active
Affected / at Risk (%) # Events
Total   79/197 (40.10%)    
Infections and infestations   
Upper respiratory tract infection  1  11/197 (5.58%)  11
Musculoskeletal and connective tissue disorders   
Back pain  1  17/197 (8.63%)  17
Arthralgia  1  13/197 (6.60%)  13
Pain in extremity  1  11/197 (5.58%)  11
Nervous system disorders   
Headache  1  27/197 (13.71%)  27
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tim Warneke
Organization: BDSI
Phone: 919-582-0294
EMail: twarneke@bdsi.com
Layout table for additonal information
Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT02355158     History of Changes
Other Study ID Numbers: CLO-311
First Submitted: November 21, 2014
First Posted: February 4, 2015
Results First Submitted: March 6, 2017
Results First Posted: July 2, 2017
Last Update Posted: September 19, 2017