An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
NCT00151528
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
- Must have received pregabalin/placebo under double-blind conditions.
- Patients may not participate in the study if they experienced a serious adverse event
during the previous fibromyalgia Study A0081056 which was determined to be related to
the study medication by the investigator or the sponsor.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Newton, Massachusetts
- Beverly Hills, California
- Beverly Hills, California
- Huntington Beach, California
- Tucson, California
- West Hills, California
- Tempe, Arizona
- Birmingham, Alabama
- Birmingham, Alabama
- Huntsville, Alabama
- Phoenix, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Beverly Hills, California
- Los Alamitos, California
- Newport Beach, California
- Northridge, California
- Pismo Beach, California
- Redondo Beach, California
- Riverside, California
- Walnut Creek, California
- Whittier, California
- Danbury, Connecticut
- New Milford, Connecticut
- Stratford, Connecticut
- Clearwater, Florida
- Miami, Florida
- Ocala, Florida
- Palm Beach Gardens, Florida
- Seminole, Florida
- St. Petersburg, Florida
- St. Petersburg, Florida
- St. Petersburg, Florida
- Sunrise, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Boise, Idaho
- Chicago, Illinois
- Maywood, Illinois
- Oak Brook, Illinois
- Peoria, Illinois
- Kansas City, Kansas
- Overland Park, Kansas
- Madisonville, Kentucky
- New Orleans, Louisiana
- Newton, Massachusetts
- Kalamazoo, Michigan
- Lansing, Michigan
- Kansas City, Missouri
- Lebanon, New Hampshire
- Princeton, New Jersey
- Albany, New York
- New York, New York
- Rochester, New York
- Charlotte, North Carolina
- Wilmington, North Carolina
- Wilmington, North Carolina
- Winston Salem, North Carolina
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Mogadore, Ohio
- Toledo, Ohio
- Oklahoma City, Oklahoma
- Eugene, Oregon
- Medford, Oregon
- Portland, Oregon
- Altoona, Pennsylvania
- Duncansville, Pennsylvania
- Johnstown, Pennsylvania
- Mechanicsburg, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Pottstown, Pennsylvania
- West Reading, Pennsylvania
- Wyomissing, Pennsylvania
- Anderson, South Carolina
- Charleston, South Carolina
- Greer, South Carolina
- Memphis, Tennessee
- Memphis, Tennessee
- Nashville, Tennessee
- Austin, Texas
- Dallas, Texas
- Lubbock, Texas
- Richardson, Texas
- San Antonio, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Woodstock, Vermont
- Virginia Beach, Virginia
- Seattle, Washington
- Seattle, Washington
- Yakima, Washington
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | An Open-Label Trial of Pregabalin in Patients With Fibromyalgia | |||
Official Title ICMJE | A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia | |||
Brief Summary | The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Fibromyalgia | |||
Intervention ICMJE | Drug: Pregabalin | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 428 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00151528 | |||
Other Study ID Numbers ICMJE | A0081057 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |