A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) (STEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01533428
First received: February 12, 2012
Last updated: March 3, 2015
Last verified: March 2015
Results First Received: February 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetic Peripheral Neuropathy
Pain
Interventions: Drug: Capsaicin 8%
Drug: Placebo

  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
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
Capsaicin 8% Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
Placebo Placebo patch was applied for 30 minutes to the painful area(s) on Day 1

Participant Flow:   Overall Study
    Capsaicin 8%     Placebo  
STARTED     186     183  
COMPLETED     177     175  
NOT COMPLETED     9     8  
Adverse Event                 0                 1  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 7                 6  



  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.
Safety Analysis Set

Reporting Groups
  Description
Capsaicin 8% Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
Placebo Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
Total Total of all reporting groups

Baseline Measures
    Capsaicin 8%     Placebo     Total  
Number of Participants  
[units: participants]
  186     183     369  
Age  
[units: years]
Mean (Standard Deviation)
  63.90  (10.64)     62.00  (10.81)     63.00  (10.75)  
Gender  
[units: participants]
     
Female     72     82     154  
Male     114     101     215  
Race/Ethnicity, Customized  
[units: participants]
     
White     132     131     263  
Black or African American     36     38     74  
Asian     4     4     8  
American Indian or Alaskan Native     2     1     3  
Native Hawaiian or Other Pacific Islander     1     2     3  
Other     11     7     18  
Duration of Painful Diabetic Peripheral Neuropathy (PDPN)  
[units: years]
Mean (Standard Deviation)
  5.83  (4.01)     5.72  (3.98)     5.78  (3.99)  
Glycosylated Hemoglobin (HbA1c)  
[units: Percentage of Glycosylated Hemoglobin]
Mean (Standard Deviation)
  7.39  (1.309)     7.23  (1.223)     7.31  (1.268)  
Average Pain Score [1]
[units: units on a scale]
Mean (Standard Deviation)
  6.64  (1.416)     6.38  (1.473)     6.51  (1.449)  
[1] Average pain was assessed by the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) on a numeric rating scale from 0 - 10, with 0 describing “no pain” and 10 describing severe pain listed as “pain as bad as you can imagine”.



  Outcome Measures
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1.  Primary:   Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8   [ Time Frame: Baseline to between Weeks 2 to 8 ]

2.  Secondary:   Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12   [ Time Frame: Baseline to between Weeks 2 and 12 ]

3.  Secondary:   Weekly Percent Change From Baseline in Average Daily Pain Score   [ Time Frame: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12 ]

4.  Secondary:   Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline   [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ]

5.  Secondary:   Percentage of Participants With 30% Reduction in Average Daily Pain Score.   [ Time Frame: Baseline, Weeks 2-8 and Weeks 2-12 ]

6.  Secondary:   Percentage of Participants With 50% Reduction in Average Daily Pain Score.   [ Time Frame: Baseline, Weeks 2-8 and Weeks 2-12 ]

7.  Secondary:   Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2   [ Time Frame: Baseline to Week 2 ]

8.  Secondary:   Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8   [ Time Frame: Baseline to Week 8 ]

9.  Secondary:   Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:   Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12   [ Time Frame: Baseline to Weeks 2, 8 and 12 ]

11.  Secondary:   Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12   [ Time Frame: Baseline to Weeks 2, 8 and 12 ]

12.  Secondary:   Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.   [ Time Frame: Baseline to Weeks 2, 8 and 12 ]

13.  Secondary:   Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12   [ Time Frame: Baseline, Weeks 8 and 12 ]

14.  Secondary:   Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12   [ Time Frame: Baseline, Weeks 2-8 and Weeks 2-12 ]

15.  Secondary:   Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.   [ Time Frame: Day 1, 15 minutes and 60 minutes after patch removal ]

16.  Secondary:   Change From Pre-application in"Pain Now" Score   [ Time Frame: Pre-application and 15 minutes and 60 minutes after patch removal ]

17.  Secondary:   Number of Participants Who Used Rescue Pain Medication Days 1 Through 5   [ Time Frame: Days 1 - 5 ]

18.  Secondary:   Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12   [ Time Frame: Baseline to 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
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.


  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: Medical Science Director, Global Medical Science
Organization: Astellas Pharma Global Development
phone: +31(0)715454002
e-mail: Astellas.resultsdisclosure@astellas.com


No publications provided


Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01533428     History of Changes
Other Study ID Numbers: E05-CL-3004
Study First Received: February 12, 2012
Results First Received: February 6, 2015
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration