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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

November 2, 2007
April 22, 2011
February 2008
January 2010   (final data collection date for primary outcome measure)
Summary of Adverse Events [ Time Frame: 53 weeks ] [ Designated as safety issue: Yes ]
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.
Safety and tolerability of pregabalin [ Time Frame: 1-52 weeks ]
Complete list of historical versions of study NCT00553280 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
  • Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
  • Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
  • 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) ] [ Designated as safety issue: No ]
    The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
  • 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) ] [ Designated as safety issue: No ]
    The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Short-Form McGill Pain Questionnaire [ Time Frame: 1-52 weeks ]
Not Provided
Not Provided
 
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Experimental: pregabalin
Intervention: Drug: pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
  • Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Exclusion Criteria:

  • Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
  • Patients exhibiting treatment non-compliance in the preceding study (A0081163)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00553280
A0081164
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP