CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
Pregabalin, then placebo +1 moredrug
Likely dose
Pregabalin, then placebo 450 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00760474
NCT00760474Phase 1Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Response To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Resonance Spectroscopy And Subjective Ratings

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 26, 2008·Updated Jan 22, 2021

In Brief

A Phase 1 clinical trial evaluating Pregabalin, then placebo and Placebo, then pregabalin for Fibromyalgia. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2008
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.8 years ago

Interventions

Pregabalin, then placebodrug

Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.

Placebo, then pregabalindrug

Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.