ClinicalTrials.gov record
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
ClinicalTrials.gov ID: NCT00645398
Public ClinicalTrials.gov record NCT00645398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
Study identification
- NCT ID
- NCT00645398
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 751 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2004
- Primary completion
- Not listed
- Completion
- May 31, 2005
- Last update posted
- Jan 24, 2021
2004 – 2005
United States locations
- U.S. sites
- 102
- U.S. states
- 30
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35294 | — |
| Pfizer Investigational Site | Huntsville | Alabama | 35801 | — |
| Pfizer Investigational Site | Paradise Valley | Arizona | 85253 | — |
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | — |
| Pfizer Investigational Site | Phoenix | Arizona | 85032 | — |
| Pfizer Investigational Site | Scottsdale | Arizona | 85254 | — |
| Pfizer Investigational Site | Hot Springs | Arkansas | 71913 | — |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | — |
| Pfizer Investigational Site | Beverly Hills | California | 90211 | — |
| Pfizer Investigational Site | Long Beach | California | 90806 | — |
| Pfizer Investigational Site | Los Alamitos | California | 90720 | — |
| Pfizer Investigational Site | Newport Beach | California | 92660 | — |
| Pfizer Investigational Site | Northridge | California | 91324-4625 | — |
| Pfizer Investigational Site | Northridge | California | 91335 | — |
| Pfizer Investigational Site | Pismo Beach | California | 93449 | — |
| Pfizer Investigational Site | Redondo Beach | California | 90277 | — |
| Pfizer Investigational Site | Riverside | California | 92501 | — |
| Pfizer Investigational Site | Riverside | California | 92506 | — |
| Pfizer Investigational Site | Walnut Creek | California | 94598 | — |
| Pfizer Investigational Site | Whittier | California | 90601 | — |
| Pfizer Investigational Site | Danbury | Connecticut | 06810 | — |
| Pfizer Investigational Site | New Milford | Connecticut | 06776 | — |
| Pfizer Investigational Site | Stratford | Connecticut | 06615 | — |
| Pfizer Investigational Site | Clearwater | Florida | 33761 | — |
| Pfizer Investigational Site | Miami | Florida | 33173 | — |
| Pfizer Investigational Site | Ocala | Florida | 34474 | — |
| Pfizer Investigational Site | Palm Beach Gardens | Florida | 33410 | — |
| Pfizer Investigational Site | Plantation | Florida | 33317 | — |
| Pfizer Investigational Site | Plantation | Florida | 33324 | — |
| Pfizer Investigational Site | St. Petersburg | Florida | 33703 | — |
| Pfizer Investigational Site | St. Petersburg | Florida | 33709 | — |
| Pfizer Investigational Site | St. Petersburg | Florida | 33710 | — |
| Pfizer Investigational Site | Sunrise | Florida | 33351-6637 | — |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | — |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | — |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | — |
| Pfizer Investigational Site | Decatur | Georgia | 30033-5930 | — |
| Pfizer Investigational Site | Boise | Idaho | 83704 | — |
| Pfizer Investigational Site | Chicago | Illinois | 60610 | — |
| Pfizer Investigational Site | Maywood | Illinois | 60153 | — |
| Pfizer Investigational Site | Oak Brook | Illinois | 60523 | — |
| Pfizer Investigational Site | Peoria | Illinois | 61614 | — |
| Pfizer Investigational Site | Kansas City | Kansas | 66160 | — |
| Pfizer Investigational Site | Overland Park | Kansas | 66210 | — |
| Pfizer Investigational Site | Overland Park | Kansas | 66215 | — |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | — |
| Pfizer Investigational Site | New Orleans | Louisiana | 70114 | — |
| Pfizer Investigational Site | Newton | Massachusetts | 02462 | — |
| Pfizer Investigational Site | East Lansing | Michigan | 48823 | — |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49009 | — |
| Pfizer Investigational Site | Lansing | Michigan | 48917 | — |
| Pfizer Investigational Site | Kansas City | Missouri | 64114 | — |
| Pfizer Investigational Site | Lebanon | New Hampshire | 03766 | — |
| Pfizer Investigational Site | Princeton | New Jersey | 08540 | — |
| Pfizer Investigational Site | Albany | New York | 12205 | — |
| Pfizer Investigational Site | New York | New York | 10003 | — |
| Pfizer Investigational Site | Rochester | New York | 14618 | — |
| Pfizer Investigational Site | Charlotte | North Carolina | 28210 | — |
| Pfizer Investigational Site | Wilmington | North Carolina | 28401 | — |
| Pfizer Investigational Site | Wilmington | North Carolina | 28403 | — |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | — |
| Pfizer Investigational Site | Columbus | Ohio | 43124 | — |
| Pfizer Investigational Site | Columbus | Ohio | 43212 | — |
| Pfizer Investigational Site | Mogadore | Ohio | 44260 | — |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | — |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73109 | — |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | — |
| Pfizer Investigational Site | Medford | Oregon | 97504 | — |
| Pfizer Investigational Site | Portland | Oregon | 97201 | — |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16601 | — |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16602 | — |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| Pfizer Investigational Site | Johnstown | Pennsylvania | 15904 | — |
| Pfizer Investigational Site | Mechanicsburg | Pennsylvania | 17055 | — |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19115 | — |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19146 | — |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15218 | — |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| Pfizer Investigational Site | Pottstown | Pennsylvania | 19610 | — |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611-1124 | — |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | — |
| Pfizer Investigational Site | Anderson | South Carolina | 29621 | — |
| Pfizer Investigational Site | Charleston | South Carolina | 29406 | — |
| Pfizer Investigational Site | Greer | South Carolina | 29651 | — |
| Pfizer Investigational Site | Memphis | Tennessee | 38104 | — |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | — |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | — |
| Pfizer Investigational Site | Austin | Texas | 78705 | — |
| Pfizer Investigational Site | Dallas | Texas | 75246 | — |
| Pfizer Investigational Site | Lubbock | Texas | 79424 | — |
| Pfizer Investigational Site | Richardson | Texas | 75080 | — |
| Pfizer Investigational Site | San Antonio | Texas | 78229-4540 | — |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | — |
| Pfizer Investigational Site | Salt Lake City | Utah | 84102 | — |
| Pfizer Investigational Site | Woodstock | Vermont | 05091-0437 | — |
| Pfizer Investigational Site | Woodstock | Vermont | 05091 | — |
| Pfizer Investigational Site | Virginia Beach | Virginia | 23454 | — |
| Pfizer Investigational Site | Seattle | Washington | 98104 | — |
| Pfizer Investigational Site | Seattle | Washington | 98122 | — |
| Pfizer Investigational Site | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00645398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2021 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00645398 live on ClinicalTrials.gov.