This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

This study has been completed.

First Received: June 28, 2006 Last Updated: March 30, 2009 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00346034

Purpose

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.

Condition	Intervention	Phase
Fibromyalgia	Drug: Pregabalin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 12 (end of treatment) ] [ Designated as safety issue: No ]

Enrollment:	357
Study Start Date:	December 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Pregabalin 150 to 600mg/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346034

Show 51 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081101
Study First Received:	June 28, 2006
Results First Received:	February 12, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00346034 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Nervous System Diseases
Physiological Effects of Drugs
Pregabalin
Rheumatic Diseases
Pharmacologic Actions
Muscular Diseases

Musculoskeletal Diseases
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010