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Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arcion Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00695565
First received: June 10, 2008
Last updated: September 21, 2016
Last verified: September 2016
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Painful Diabetic Neuropathy
Interventions: Drug: Placebo Gel
Drug: Clonidine Topical Gel (ARC-4558)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from May 2008 until September 2009. All study sites were medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects were required to meet all eligibility criteria at both the Screening and Baseline visits. If a subject met the Screening criteria but not the Baseline criteria, the subject was not eligible for enrollment.

Two subjects were randomized but were not treated because they were found ineligible. They are not counted in the 180 enrolled.


Reporting Groups
  Description
Placebo Gel Placebo Gel is vehicle without clonidine
Clonidine Topical Gel (ARC-4558) Clonidine Topical Gel contains 0.1% clonidine hydrochloride

Participant Flow:   Overall Study
    Placebo Gel   Clonidine Topical Gel (ARC-4558)
STARTED   90   90 
COMPLETED   77   81 
NOT COMPLETED   13   9 
Lost to Follow-up                4                4 
Adverse Event                3                1 
Protocol Violation                3                1 
Withdrawal by Subject                1                1 
Lack of Efficacy                1                1 
Subject did not follow instructions                1                1 



  Baseline Characteristics
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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.
ITT (Intent-to-Treat)

Reporting Groups
  Description
Placebo Gel Placebo Gel is vehicle without clonidine
Clonidine Topical Gel (ARC-4558) Clonidine Topical Gel contains 0.1% clonidine hydrochloride
Total Total of all reporting groups

Baseline Measures
   Placebo Gel   Clonidine Topical Gel (ARC-4558)   Total 
Overall Participants Analyzed 
[Units: Participants]
 90   90   180 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (9.5)   59.4  (9.9)   58.5  (9.7) 
Gender 
[Units: Participants]
     
Female   48   46   94 
Male   42   44   86 
Region of Enrollment 
[Units: Participants]
     
United States   90   90   180 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation   [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84) ]

2.  Secondary:   Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation   [ Time Frame: Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages) ]

3.  Secondary:   Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation   [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ]

4.  Secondary:   Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation   [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ]

5.  Secondary:   Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation   [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ]

6.  Secondary:   Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Patient Global Impression of Change (PGIC) at Week 12   [ Time Frame: Week 12 ]

13.  Secondary:   Clinician Global Impression of Change (CGIC) at Week 12   [ Time Frame: Week 12 ]

14.  Secondary:   Change in Blood Pressure From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. James Campbell
Organization: Arcion Therapeutics, Inc.
phone: (410) 522-8701
e-mail: jcampbell@arciontherapeutics.com


Publications of Results:

Responsible Party: Arcion Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00695565     History of Changes
Other Study ID Numbers: CLO-027
Study First Received: June 10, 2008
Results First Received: July 11, 2013
Last Updated: September 21, 2016
Health Authority: United States: Food and Drug Administration