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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00553280
• Date of registration: 02/11/2007
• Primary sponsor: Pfizer
• Public title: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
• Scientific title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
• Date of first enrolment: February 2008
• Target sample size: 123
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00553280
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Neuropathy, Painful

Intervention(s)

Drug: pregabalin

Primary Outcome(s)

Summary of Adverse Events [Time Frame: 53 weeks]

Secondary Outcome(s)

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

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)]

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

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

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)]

Secondary ID(s)

A0081164

Source(s) of Monetary Support

Please refer to primary and secondary sponsors