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

Diabetic Neuropathy, Painful Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553280
• Other study ID #: A0081164
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Arakawa	Tokyo
Japan	Pfizer Investigational Site	Beppu	Oita
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Date-shi	Fukushima
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hirano-ku	Osaka
Japan	Pfizer Investigational Site	Kamakura	Kanagawa
Japan	Pfizer Investigational Site	Matsumoto	Nagano
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Naha	Okinawa
Japan	Pfizer Investigational Site	Nihonmatsu	Fukushima
Japan	Pfizer Investigational Site	Ohta-ku	Tokyo
Japan	Pfizer Investigational Site	Oita
Japan	Pfizer Investigational Site	Oyama-shi	Tochigi
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Shibuya-ku	Tokyo
Japan	Pfizer Investigational Site	Shirakawa-shi	Fukushima
Japan	Pfizer Investigational Site	Sukagawa	Fukushima
Japan	Pfizer Investigational Site	Suminoe-ku	Osaka
Japan	Pfizer Investigational Site	Sunto-gun	Shizuoka
Japan	Pfizer Investigational Site	Tokushima
Japan	Pfizer Investigational Site	Tomishiro	Okinawa
Japan	Pfizer Investigational Site	Ueda	Nagano
Japan	Pfizer Investigational Site	Urazoe	Okinawa
Japan	Pfizer Investigational Site	Yamada	Okayama
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Adverse Events	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.	53 weeks
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores	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.	From baseline to 52 weeks or study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores	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.	From baseline to 52 weeks or study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores	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.	From baseline to 52 weeks or study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores	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.	From baseline to 52 weeks or study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores	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.	From baseline to 52 weeks or study discontinuation (Study Endpoint)

External Links

•   To obtain contact information for a study center near you, click here.