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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 150 to 600mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score | Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind. | Week 4 |
| Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score | Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind. | Week 12 (end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 2H4 | Canada | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22503162 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.
The study was planned to include all eligible subjects continuing from the preceding double-blind study A0081100 NCT00333866 (Subjects had to be at least 18 years old and have met the American College of Rheumatology criteria for fibromyalgia).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Winnipeg |
| Manitoba |
| R3A 1R9 |
| Canada |
| Pfizer Investigational Site | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Pfizer Investigational Site | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M3K 2A7 | Canada |
| Pfizer Investigational Site | Drummondville | Quebec | J2B 7T1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3T 1E2 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 3M7 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Pfizer Investigational Site | Frederiksberg | 2000 | Denmark |
| Pfizer Investigational Site | Svendborg | 5700 | Denmark |
| Pfizer Investigational Site | Montpellier | Cedex 5 | 34295 | France |
| Pfizer Investigational Site | Lille | Cedex | 59037 | France |
| Pfizer Investigational Site | Clermont-Ferrand | 63003 | France |
| Pfizer Investigational Site | Paris | 75181 | France |
| Pfizer Investigational Site | Saint-Priest-en-Jarez | 42270 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Berlin | 14109 | Germany |
| Pfizer Investigational Site | Mannheim | 68161 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | Indore | Madhya Pradesh | 452001 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 001 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 008 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226 014 | India |
| Pfizer Investigational Site | Bari | 79124 | Italy |
| Pfizer Investigational Site | Benevento | 82100 | Italy |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Chieti Scalo | 66013 | Italy |
| Pfizer Investigational Site | Pisa | Italy |
| Pfizer Investigational Site | Alkmaar | 1815 JD | Netherlands |
| Pfizer Investigational Site | Den Helder | 1782 GZ | Netherlands |
| Pfizer Investigational Site | Leeuwarden | 8934 AD | Netherlands |
| Pfizer Investigational Site | Zwolle | 8011 JW | Netherlands |
| Pfizer Investigational Site | Lisbon | 1700-360 | Portugal |
| Pfizer Investigational Site | Suwon | Kyeongki-do | 442-712 | South Korea |
| Pfizer Investigational Site | Seoul | 133-792 | South Korea |
| Pfizer Investigational Site | Seoul | 143-914 | South Korea |
| Pfizer Investigational Site | Linköping | 581 85 | Sweden |
| Pfizer Investigational Site | Mölndal | 431 37 | Sweden |
| Pfizer Investigational Site | Örebro | 701 85 | Sweden |
| Pfizer Investigational Site | Stockholm | SE-112 81 | Sweden |
| Pfizer Investigational Site | Zurich | 8063 | Switzerland |
| Pfizer Investigational Site | Zurich | 8091 | Switzerland |
| Pfizer Investigational Site | Manchester | Greater Manchester | M6 8HD | United Kingdom |
| Pfizer Investigational Site | Greenock | Renfrewshire | PA16 0XN | United Kingdom |
| Pfizer Investigational Site | North Shields | Tyne and Wear | NE29 8NH | United Kingdom |
| Pfizer Investigational Site | London | WC1X 8LD | United Kingdom |
| Pfizer Investigational Site | Poole | BH12 2JB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score | Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind. | This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4. | Posted | Mean | Standard Deviation | mm | Week 4 |
|
|
| |||||||||||||||||||||||||
| Primary | Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score | Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind. | This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12. | Posted | Mean | Standard Deviation | mm | Week 12 (end of treatment) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin. | 6 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | medDRA (v11.1) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | medDRA (v11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | medDRA (v11.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | medDRA (v11.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | medDRA (v11.1) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | medDRA (v11.1) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Injury, poisoning and procedural complications | medDRA (v11.1) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | medDRA (v11.1) | Non-systematic Assessment |
| |
| Vulva cyst | Reproductive system and breast disorders | medDRA (v11.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | medDRA (v11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (v11.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (v11.1) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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