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A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy (Pregabalin)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00573261
First received: December 12, 2007
Last updated: July 11, 2014
Last verified: July 2013
Results First Received: December 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetic Neuropathy
Interventions: Drug: Pregabalin
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
Subjects were recruited from the outpatient endocrine clinics of a tertiary academic center and locally via advertisement between March 3, 2006 and April 1, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 4 subjects who provided study consent but did not complete the baseline assessment because of unwillingness to wear the LifeShirt monitor (n=2 in placebo arm) and inability of keeping baseline assessment appointment due to job reassignment (n=2 in pregabalin arm).

Reporting Groups
  Description
Placebo

Placebo

Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.

Pregabalin

Pregabalin medication

Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.


Participant Flow:   Overall Study
    Placebo   Pregabalin
STARTED   20   20 
COMPLETED   14   15 
NOT COMPLETED   6   5 



  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.
No text entered.

Reporting Groups
  Description
Pregabalin

Pregabalin medication

Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.

Placebo

Placebo

Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.

Total Total of all reporting groups

Baseline Measures
   Pregabalin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   13   29 
>=65 years   4   7   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (14.36)   59.65  (12.5)   57.4  (13.5) 
Gender 
[Units: Participants]
     
Female   9   6   15 
Male   11   14   25 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures
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1.  Primary:   Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

2.  Primary:   Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

3.  Primary:   Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

4.  Primary:   Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

5.  Primary:   Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

6.  Primary:   Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

7.  Primary:   Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.   [ Time Frame: baseline and at end of a 4-week intervention ]

8.  Secondary:   To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.   [ Time Frame: baseline and end of 4 week intervention ]

9.  Secondary:   To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.   [ Time Frame: baseline and at end of a 4-week intervention ]

10.  Secondary:   To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.   [ Time Frame: baseline and at end of a 4-week intervention ]

11.  Secondary:   To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.   [ Time Frame: baseline and at end of a 4-week intervention ]


  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
The study has a high dropout, which might have reduced the power of the analysis. One of the major reasons that many patients were not able to participate was an inability to commit to the relatively intense and frequent assessments.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Wei Jiang
Organization: Duke University Medical Center
phone: 919-668-0762
e-mail: weijiang@duke.edu


Publications of Results:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00573261     History of Changes
Other Study ID Numbers: Pro00009557
2005-0003 ( Other Identifier: Pfizer )
7511-05-8 ( Other Identifier: Duke legacy protocol number )
Study First Received: December 12, 2007
Results First Received: December 21, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board