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Trial record 10 of 325 for:    clonidine

The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT02643251
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : August 9, 2017
Last Update Posted : September 20, 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 Hydrochloride Topical Gel, 0.1%
Drug: Clonidine Hydrochloride Gel Comparator
Enrollment 138
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Hide Arm/Group Description

Clonidine Hydrochloride Topical Gel, 0.1%

Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.

Clonidine Hydrochloride Gel Comparator

Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Period Title: Overall Study
Started 69 69
Completed 58 67
Not Completed 11 2
Reason Not Completed
Adverse Event             3             1
Withdrawal by Subject             2             0
Lost to Follow-up             4             1
Protocol Violation             1             0
PI Decision to terminate patient             1             0
Arm/Group Title Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator Total
Hide Arm/Group Description

Clonidine Hydrochloride Topical Gel, 0.1%

Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.

Clonidine Hydrochloride Gel Comparator

Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Total of all reporting groups
Overall Number of Baseline Participants 69 69 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  73.9%
47
  68.1%
98
  71.0%
>=65 years
18
  26.1%
22
  31.9%
40
  29.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 69 participants 138 participants
59.3  (8.76) 59.7  (10.00) 59.5  (9.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
Female
39
  56.5%
39
  56.5%
78
  56.5%
Male
30
  43.5%
30
  43.5%
60
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
Hispanic or Latino
15
  21.7%
15
  21.7%
30
  21.7%
Not Hispanic or Latino
54
  78.3%
54
  78.3%
108
  78.3%
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 69 participants 69 participants 138 participants
American Indian or Alaska Native
1
   1.4%
0
   0.0%
1
   0.7%
Asian
1
   1.4%
2
   2.9%
3
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  26.1%
24
  34.8%
42
  30.4%
White
49
  71.0%
43
  62.3%
92
  66.7%
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 69 participants 69 participants 138 participants
69 69 138
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])
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Hide Arm/Group Description:

Clonidine Hydrochloride Topical Gel, 0.1%

Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.

Clonidine Hydrochloride Gel Comparator

Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Overall Number of Participants Analyzed 58 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (1.395) -1.4  (1.526)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine Hydrochloride Topical Gel, 0.1%, Clonidine Hydrochloride Gel Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3361
Comments [Not Specified]
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 (worse score from Day -14 to Day -8) to End-of-Treatment (worse score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worse 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 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 (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Hide Arm/Group Description:

Clonidine Hydrochloride Topical Gel, 0.1%

Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.

Clonidine Hydrochloride Gel Comparator

Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Overall Number of Participants Analyzed 58 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.29  (1.734) -1.48  (1.667)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Hide Arm/Group Description

Clonidine Hydrochloride Topical Gel, 0.1%

Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.

Clonidine Hydrochloride Gel Comparator

Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

All-Cause Mortality
Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)      0/69 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/69 (2.90%)      6/69 (8.70%)    
Blood and lymphatic system disorders     
Anemia   0/69 (0.00%)  0 1/69 (1.45%)  1
Cardiac disorders     
Cardiac Failure Congestive   1/69 (1.45%)  1 0/69 (0.00%)  0
Ventricular tachycardia   1/69 (1.45%)  1 0/69 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea   0/69 (0.00%)  0 1/69 (1.45%)  1
Pancreatitis   0/69 (0.00%)  0 1/69 (1.45%)  1
General disorders     
Chest Pain   0/69 (0.00%)  0 1/69 (1.45%)  1
Infections and infestations     
Perirectal absess   0/69 (0.00%)  0 1/69 (1.45%)  1
Metabolism and nutrition disorders     
dehydration   1/69 (1.45%)  1 0/69 (0.00%)  0
Gout   0/69 (0.00%)  0 1/69 (1.45%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema   0/69 (0.00%)  0 1/69 (1.45%)  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%
Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Gel Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/69 (5.80%)      2/69 (2.90%)    
Nervous system disorders     
Headache   4/69 (5.80%)  4 2/69 (2.90%)  2
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: NCT02643251     History of Changes
Other Study ID Numbers: CLO-291
First Submitted: December 29, 2015
First Posted: December 31, 2015
Results First Submitted: June 2, 2017
Results First Posted: August 9, 2017
Last Update Posted: September 20, 2017