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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clonidine Gel 0.1%

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo

Placebo gel of identical appearance as active treatment

Placebo


Participant Flow:   Overall Study
    Clonidine Gel 0.1%   Placebo
STARTED   130   130 
COMPLETED   117   114 
NOT COMPLETED   13   16 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clonidine Gel 0.1%

Clonidine hydrochloride topical gel, 0.1%

Clonidine Gel 0.1%

Placebo

Placebo gel of identical appearance as active treatment

Placebo

Total Total of all reporting groups

Baseline Measures
   Clonidine Gel 0.1%   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 130   130   260 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.58  (10.458)   59.64  (11.226)   60.11  (10.838) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      50  38.5%      58  44.6%      108  41.5% 
Male      80  61.5%      72  55.4%      152  58.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   130   130   260 


  Outcome Measures

1.  Primary:   Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score   [ 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]) ]

2.  Secondary:   Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores   [ 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]) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: twarneke@bdsi.com



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