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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00346034
First received: June 28, 2006
Last updated: March 30, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Resource links provided by NLM:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Canada, British Columbia
Pfizer Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, New Brunswick
Pfizer Investigational Site
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Newfoundland and Labrador
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
Pfizer Investigational Site
Hawkesbury, Ontario, Canada, K6A 1A1
Pfizer Investigational Site
Toronto, Ontario, Canada, M3K 2A7
Canada, Quebec
Pfizer Investigational Site
Drummondville, Quebec, Canada, J2B 7T1
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Pfizer Investigational Site
Pointe Claire, Quebec, Canada, H9R 3J1
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 3M7
Denmark
Pfizer Investigational Site
Frederiksberg, Denmark, 2000
Pfizer Investigational Site
Svendborg, Denmark, 5700
France
Pfizer Investigational Site
Montpellier, Cedex 5, France, 34295
Pfizer Investigational Site
Lille, Cedex, France, 59037
Pfizer Investigational Site
Clermont Ferrand Cedex 1, France, 63003
Pfizer Investigational Site
Paris Cedex 04, France, 75181
Pfizer Investigational Site
Saint Priest En Jarez, France, 42270
Germany
Pfizer Investigational Site
Berlin, Germany, 14109
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Mannheim, Germany, 68161
Pfizer Investigational Site
Muenchen, Germany, 80336
India
Pfizer Investigational Site
Indore, Madhya Pradesh, India, 452001
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 008
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 001
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 014
Italy
Pfizer Investigational Site
Bari, Italy, 79124
Pfizer Investigational Site
Benevento, Italy, 82100
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Chieti Scalo, Italy, 66013
Pfizer Investigational Site
Pisa, Italy
Korea, Republic of
Pfizer Investigational Site
Suwon-si, Kyeongki-do, Korea, Republic of, 442-712
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-914
Pfizer Investigational Site
Seoul, Korea, Republic of, 133-792
Netherlands
Pfizer Investigational Site
Alkmaar, Netherlands, 1815 JD
Pfizer Investigational Site
Den Helder, Netherlands, 1782 GZ
Pfizer Investigational Site
Leeuwarden, Netherlands, 8934 AD
Pfizer Investigational Site
Zwolle, Netherlands, 8011 JW
Portugal
Pfizer Investigational Site
Lisbon, Portugal, 1700-360
Sweden
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Molndal, Sweden, 431 37
Pfizer Investigational Site
Orebro, Sweden, 701 85
Pfizer Investigational Site
Stockholm, Sweden, SE-112 81
Switzerland
Pfizer Investigational Site
Zurich, Switzerland, 8091
Pfizer Investigational Site
Zürich, Switzerland, 8063
United Kingdom
Pfizer Investigational Site
Manchester, Greater Manchester, United Kingdom, M6 8HD
Pfizer Investigational Site
Greenock, Renfrewshire, United Kingdom, PA16 0XN
Pfizer Investigational Site
North Shields, Tyne and Wear, United Kingdom, NE29 8NH
Pfizer Investigational Site
London, United Kingdom, WC1X 8LD
Pfizer Investigational Site
Poole, United Kingdom, BH12 2JB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014