NCT02215252

A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	PF-05089771 150 mg	PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
DRUG	Matched placebo for PF-05089771 150 mg and pregabalin 300 mg	Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
DRUG	Pregabalin 300 mg	Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
DRUG	PF-05089771 150 mg + Pregabalin 300 mg	PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.

Timeline

• Start date: 2014-11-10
• Primary completion: 2015-07-15
• Completion: 2015-09-28
• First posted: 2014-08-13
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study