NCT01432236

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Pregabalin	Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
DRUG	placebo	placebo capsules twice a day for 14 weeks

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-09-12
• Last updated: 2021-01-22
• Results posted: 2014-10-22

Locations

37 sites across 4 countries: United States, Canada, Italy, Spain