A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00553280
First received: November 2, 2007
Last updated: April 22, 2011
Last verified: April 2011
Results First Received: December 7, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Neuropathy, Painful
Intervention: Drug: pregabalin

  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
Thirty-six (36) centers in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with pain associated with diabetic peripheral neuropathy who had completed the 13-week treatment phase in the preceding study (Study A0081163: NCT00553475), without any treatment-related serious adverse events or any compliance problems were eligible for the study.

Reporting Groups
  Description
Pregabalin Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     123  
COMPLETED     97  
NOT COMPLETED     26  
Adverse Event                 19  
Lack of Efficacy                 3  
Withdrawal by Subject                 3  
Physician Decision                 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.
No text entered.

Reporting Groups
  Description
Pregabalin Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  123  
Age, Customized  
[units: participants]
 
< 18 years     0  
18 - 44 years     6  
45 - 64 years     71  
>= 65 years     46  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  61.7  ± 10.0  
Gender  
[units: participants]
 
Female     23  
Male     100  



  Outcome Measures
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1.  Primary:   Summary of Adverse Events   [ Time Frame: 53 weeks ]

2.  Secondary:   Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores   [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

3.  Secondary:   Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores   [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

4.  Secondary:   Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores   [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

5.  Secondary:   Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores   [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

6.  Secondary:   Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores   [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00553280     History of Changes
Other Study ID Numbers: A0081164
Study First Received: November 2, 2007
Results First Received: December 7, 2010
Last Updated: April 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare