Status:
COMPLETED
Pregabalin Peripheral Neuropathic Pain Study
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Diabetic Neuropathies
Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropat...
Eligibility Criteria
Inclusion
- Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
- Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).
Exclusion
- Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
- Creatinine clearance \< 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00141219
Start Date
December 1 2005
End Date
December 1 2007
Last Update
February 9 2021
Active Locations (10)
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1
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, South Korea, 463-802
2
Pfizer Investigational Site
Suwon, Gyeonggi-do, South Korea, 443-721
3
Pfizer Investigational Site
Busan, South Korea, 602-739
4
Pfizer Investigational Site
Daegu, South Korea, 705-715