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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
  Purpose

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


Condition Intervention Phase
Diabetic Neuropathy, Painful
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 123
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pregabalin Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553280

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Date-shi, Fukushima, Japan
Pfizer Investigational Site
Nihonmatsu, Fukushima, Japan
Pfizer Investigational Site
Shirakawa-shi, Fukushima, Japan
Pfizer Investigational Site
Sukagawa, Fukushima, Japan
Pfizer Investigational Site
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Matsumoto, Nagano, Japan
Pfizer Investigational Site
Ueda, Nagano, Japan
Pfizer Investigational Site
Beppu, Oita, Japan
Pfizer Investigational Site
Yamada, Okayama, Japan
Pfizer Investigational Site
Naha, Okinawa, Japan
Pfizer Investigational Site
Tomishiro, Okinawa, Japan
Pfizer Investigational Site
Urazoe, Okinawa, Japan
Pfizer Investigational Site
Hirano-ku, Osaka, Japan
Pfizer Investigational Site
Suminoe-ku, Osaka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Oyama-shi, Tochigi, Japan
Pfizer Investigational Site
Arakawa, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Ohta-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Oita, Japan
Pfizer Investigational Site
Tokushima, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014