Status:
COMPLETED
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
Eligibility Criteria
Inclusion
- Males or females at least 18 years of age, of any ethnic origin
- Type 1 or 2 diabetes mellitus
- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
Exclusion
- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00143156
Start Date
March 1 2005
End Date
May 1 2007
Last Update
January 22 2021
Active Locations (54)
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1
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35406
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
4
Pfizer Investigational Site
La Mesa, California, United States, 91942