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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020300-29 | EudraCT Number |
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The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | Oral capsule 75-450 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Numeric Rating Scale by Week | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. | Baseline, Weeks 3, 8, 16, 24 and Last Visit. |
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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 |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Apex Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27475753 | Derived | Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 63 participants were screened and enrolled at 19 study centers in this open-label extension study to the parent double-blind randomized fibromyalgia study A0081180.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Santa Ana |
| California |
| 92705 |
| United States |
| Florida Medical Center & Research | Miami | Florida | 33142 | United States |
| Harmony Clinical Research, Incorporated | North Miami Beach | Florida | 33162 | United States |
| Rheumatology Associates of Central Florida, PA | Orlando | Florida | 32806 | United States |
| Medical Research & Health Education Foundation, Inc. | Columbus | Georgia | 31909 | United States |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University Pediatric Rheumatology of Kentucky, LLC | Louisville | Kentucky | 40202 | United States |
| University of Massachusetts Memorial Medical Center Department of Pediatrics | Worcester | Massachusetts | 01655 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Akron Children's Hospital-Mahoning Valley | Boardman | Ohio | 44512 | United States |
| Akron Children's Hospital | Boardman | Ohio | 44512 | United States |
| University of Cincinnati Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Medical University of South Carolina, Pediatric Rheumatology | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Carolina Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Fatigue Consultation Clinic | Salt Lake City | Utah | 84102 | United States |
| Bioregeneracni a rehabilitacni centrum | Říčany | 25101 | Czechia |
| Krishna Institute of Medical Sciences Ltd | Secunderabad | Andhra Pradesh | 500 003 | India |
| Mallikatta Neuro Center | Mangalore | Karnataka | 575002 | India |
| Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics | Nagpur | Maharashtra | 440010 | India |
| King George's Medical University | Lucknow | Uttar Pradesh | 226 018 | India |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. |
| 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 |
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| 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 in Pain Numeric Rating Scale by Week | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. | This population will include all participants who have received at least one dose of study medication. | Posted | Mean | Standard Deviation | Number | Baseline, Weeks 3, 8, 16, 24 and Last Visit. |
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Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
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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 | Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. | 3 | 63 | 32 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (v18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (v18.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v18.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (v18.0) | Non-systematic Assessment | The number of females is 53 out of 63 participants and dysmenorrhoea occurs in females only thus exceeds 5%. |
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| Fatigue | General disorders | MedDRA (v18.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | Non-systematic Assessment |
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Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@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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| Title | Measurements |
|---|---|
|
| Week 16 (N=51) |
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| Week 24 (N=55) |
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| Last Visit (N=63) |
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