NCT00553475

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	placebo	Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
DRUG	pregabalin	Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
DRUG	pregabalin	Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-11-05
• Last updated: 2021-01-25
• Results posted: 2010-06-22

Locations

49 sites across 1 country: Japan