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Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

Last updated on February 28, 2019

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Study Location
Southwest hospital of the third military medical university/Department of Neurology
Chongqing, Chongqing, 400038 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and female subjects aged 18 years or older

- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to
diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6
months to 5 years (inclusive).

- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue
Scale, at randomization, subjects must have completed at least 5 daily pain
interference diaries, and have an average daily pain score of ≥5 over the past 7 days.

- Patient who are willing and capable to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Women of childbearing potential are willing to use contraception during study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization
as compared to screening; and during the 1 week screening period, with more than one
pain score

- Subject has other kinds of neurological disorder, pain of other reason, or skin
condition that could confuse the assessment.

- Subject with any other serious or unstable condition which in the opinion of the
investigator might compromise participation in the study.

NCT01332149
Pfizer
Completed
Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

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[email protected]

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