This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00346034
First received: June 28, 2006
Last updated: March 30, 2009
Last verified: March 2009
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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:
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 |
|---|---|
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346034
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| 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 Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013