ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With 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: NCT02068027
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : August 24, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Painful Diabetic Neuropathy
Diabetic Neuropathy
Neuropathy
Interventions Drug: Clonidine Gel 0.1%
Drug: Placebo
Enrollment 260
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clonidine Gel 0.1% Placebo
Hide Arm/Group Description

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo gel of identical appearance as active treatment

Placebo

Period Title: Overall Study
Started 130 130
Completed 117 114
Not Completed 13 16
Arm/Group Title Clonidine Gel 0.1% Placebo Total
Hide Arm/Group Description

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo gel of identical appearance as active treatment

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 130 130 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 130 participants 260 participants
60.58  (10.458) 59.64  (11.226) 60.11  (10.838)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
Female
50
  38.5%
58
  44.6%
108
  41.5%
Male
80
  61.5%
72
  55.4%
152
  58.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
Hispanic or Latino
18
  13.8%
32
  24.6%
50
  19.2%
Not Hispanic or Latino
112
  86.2%
98
  75.4%
210
  80.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
American Indian or Alaska Native
2
   1.5%
1
   0.8%
3
   1.2%
Asian
3
   2.3%
1
   0.8%
4
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
30
  23.1%
31
  23.8%
61
  23.5%
White
95
  73.1%
97
  74.6%
192
  73.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 130 participants 130 participants 260 participants
130 130 260
1.Primary Outcome
Title Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score
Hide Description The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “average pain in the past 24 hours in the painful areas of the feet” averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.
Time Frame The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Gel 0.1% Placebo
Hide Arm/Group Description:

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo gel of identical appearance as active treatment

Placebo

Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (0.17) -1.6  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Gel 0.1%, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4503
Comments MMRM imputing for missing data
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores
Hide Description The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worst pain in the past 24 hours in the painful areas of the feet” from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.
Time Frame The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Gel 0.1% Placebo
Hide Arm/Group Description:

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo gel of identical appearance as active treatment

Placebo

Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.4  (0.11) -1.4  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Gel 0.1%, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7350
Comments MMRM imputing for missing data
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine Gel 0.1% Placebo
Hide Arm/Group Description

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo gel of identical appearance as active treatment

Placebo

All-Cause Mortality
Clonidine Gel 0.1% Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/130 (0.00%)      0/130 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Gel 0.1% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/130 (9.23%)      7/130 (5.38%)    
Cardiac disorders     
Acute myocardial infarction   1/130 (0.77%)  1 1/130 (0.77%)  1
Arrhythmia   0/130 (0.00%)  0 1/130 (0.77%)  1
Atrial fibrillation   1/130 (0.77%)  1 0/130 (0.00%)  0
Bradycardia   1/130 (0.77%)  1 0/130 (0.00%)  0
Ischaemic cardiomyophathy   1/130 (0.77%)  1 0/130 (0.00%)  0
Gastrointestinal disorders     
Colitis   0/130 (0.00%)  0 1/130 (0.77%)  1
Duodenal ulcer   1/130 (0.77%)  1 0/130 (0.00%)  0
Oesophagitits   0/130 (0.00%)  0 1/130 (0.77%)  1
General disorders     
Non-cardiac chest pain   1/130 (0.77%)  1 0/130 (0.00%)  0
Pain   0/130 (0.00%)  0 1/130 (0.77%)  1
Injury, poisoning and procedural complications     
Post procedural haemorrhage   1/130 (0.77%)  1 0/130 (0.00%)  0
Investigations     
Electrocardiogram t wave inversion   1/130 (0.77%)  1 0/130 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia   0/130 (0.00%)  0 1/130 (0.77%)  1
Musculoskeletal and connective tissue disorders     
Back pain   1/130 (0.77%)  1 0/130 (0.00%)  0
Lumbar spinal stenosis   1/130 (0.77%)  1 0/130 (0.00%)  0
Osteoarthritis   1/130 (0.77%)  1 0/130 (0.00%)  0
Nervous system disorders     
Ischaemic stroke   1/130 (0.77%)  1 0/130 (0.00%)  0
Syncope   0/130 (0.00%)  0 1/130 (0.77%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration   1/130 (0.77%)  1 0/130 (0.00%)  0
Vascular disorders     
Arterial stenosis   1/130 (0.77%)  1 0/130 (0.00%)  0
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%
Clonidine Gel 0.1% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/130 (29.23%)      58/130 (44.62%)    
General disorders     
Oedema peripheral   7/130 (5.38%)  7 3/130 (2.31%)  3
Infections and infestations     
Upper respiratory tract infection   5/130 (3.85%)  5 7/130 (5.38%)  7
Musculoskeletal and connective tissue disorders     
Back pain   7/130 (5.38%)  7 11/130 (8.46%)  11
Pain in extrimity   2/130 (1.54%)  2 8/130 (6.15%)  8
Nervous system disorders     
Heachache   10/130 (7.69%)  10 20/130 (15.38%)  20
Skin and subcutaneous tissue disorders     
Dry Skin   3/130 (2.31%)  3 8/130 (6.15%)  8
Hyperkeratosis   7/130 (5.38%)  7 1/130 (0.77%)  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
Name/Title: Vice President Clinical Operations
Organization: BDSI
Phone: 919-582-0294
Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT02068027     History of Changes
Other Study ID Numbers: CLO-290
First Submitted: February 19, 2014
First Posted: February 20, 2014
Results First Submitted: March 6, 2017
Results First Posted: August 24, 2017
Last Update Posted: September 26, 2017