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Completed

NCT Number: NCT00553280

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin 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

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin

Drug

Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Primary outcomes

  1. Summary of Adverse Events

    Time frame: 53 weeks

    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.

Secondary outcomes

  1. Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

    Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

    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.

  2. Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

    Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

    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.

  3. Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

    Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

    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.

  4. 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)

    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.

  5. 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)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 5, 2007
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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