- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00725101
Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM.
The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize management of FM. This study will address current gaps in a rapidly growing body of literature on FM.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Cidra, Porto Rico, 00739
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hato Rey, Porto Rico, 00920
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Humacao, Porto Rico, 00791
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Levittown, Porto Rico, 00949
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Manati, Porto Rico, 00674
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Mayaguez, Porto Rico, 00680
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Rio Piedras, Porto Rico, 00921
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San German, Porto Rico, 00683
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Santa Isabel, Porto Rico, 00757
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Arkansas
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Hot Springs, Arkansas, Stati Uniti, 71913
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California
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Santa Barbara, California, Stati Uniti, 93108
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
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Waterbury, Connecticut, Stati Uniti, 06708
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20006
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Florida
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Jupiter, Florida, Stati Uniti, 33458
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Tampa, Florida, Stati Uniti, 33609
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Winter Park, Florida, Stati Uniti, 32792
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Georgia
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Blue Ridge, Georgia, Stati Uniti, 30513
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Snellville, Georgia, Stati Uniti, 30078
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Idaho
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Meridian, Idaho, Stati Uniti, 83646
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Nampa, Idaho, Stati Uniti, 83686
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Illinois
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Peoria, Illinois, Stati Uniti, 61614
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Illinois, Stati Uniti, 62702
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Evansville, Indiana, Stati Uniti, 47710
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fishers, Indiana, Stati Uniti, 46038
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Indianapolis, Indiana, Stati Uniti, 46260
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40223
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Baltimore, Maryland, Stati Uniti, 21222
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Towson, Maryland, Stati Uniti, 21286
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wheaton, Maryland, Stati Uniti, 20902
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Michigan
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Lansing, Michigan, Stati Uniti, 48910
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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West Plains, Missouri, Stati Uniti, 65775
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Reno, Nevada, Stati Uniti, 89502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Dover, New Jersey, Stati Uniti, 07801
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East Brunswick, New Jersey, Stati Uniti, 08816
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Medford, New Jersey, Stati Uniti, 08055
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Schenectady, New York, Stati Uniti, 12308
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Boone, North Carolina, Stati Uniti, 28607
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Charlotte, North Carolina, Stati Uniti, 28210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Dakota
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Minot, North Dakota, Stati Uniti, 58701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cleveland, Ohio, Stati Uniti, 44195
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Findlay, Ohio, Stati Uniti, 45840
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Duncansville, Pennsylvania, Stati Uniti, 16635
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Reading, Pennsylvania, Stati Uniti, 19611
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Arlington, Texas, Stati Uniti, 76011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dallas, Texas, Stati Uniti, 75278
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Flower Mound, Texas, Stati Uniti, 75028
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Garland, Texas, Stati Uniti, 75042
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Grand Prairie, Texas, Stati Uniti, 75050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Houston, Texas, Stati Uniti, 77034
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Utah
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Salt Lake City, Utah, Stati Uniti, 84102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Kirkland, Washington, Stati Uniti, 98034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seattle, Washington, Stati Uniti, 98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Beckley, West Virginia, Stati Uniti, 25801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Meet criteria for fibromyalgia (FM) in the opinion of the investigator
- Must be prescribed a 'new' treatment for FM
- Male and female participants at least 18 years of age
- Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation
- Currently under the care of the participating physician
- Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI)
- Available for 12 months to participate in the study
Exclusion Criteria:
- Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Are Lilly employees
- Are Terminally ill
- Currently participating in other research studies or if beginning a research study while participating in this study
- Unable to respond via telephone for CATI
- Incompetent for interview as deemed by the participating physician
- Unwilling to provide written ICD or other required forms to participate in the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Fibromyalgia (FM) Participants
FM participants starting any new pharmacologic FM agent.
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FM participants starting any new pharmacologic FM agent.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Lasso di tempo: Baseline through 12 months
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Baseline through 12 months
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Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication
Lasso di tempo: Baseline through 12 months
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Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.
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Baseline through 12 months
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Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
Lasso di tempo: Baseline through 12 months
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Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety).
Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.
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Baseline through 12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Lasso di tempo: Baseline through 12 months
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Participants were allowed to select multiple reasons for discontinuing treatment.
During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once.
A reason for discontinuation was given each time a participant stopped taking a medication.
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Baseline through 12 months
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Percentage of Participants Who Discontinued Opioids
Lasso di tempo: Baseline through 12 months
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Baseline through 12 months
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Hazard Ratios for Factors Associated With Discontinued Opioid Use
Lasso di tempo: Baseline through 12 months
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Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.
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Baseline through 12 months
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Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Lasso di tempo: Baseline, 12 months
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Average BPI-I measures self-reported degree of pain interference on function.
Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Average interference = average of non-missing scores of individual interference items.
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Baseline, 12 months
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Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
Lasso di tempo: Baseline, 12 months
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BPI-S measures self-reported severity of pain.
Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.
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Baseline, 12 months
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Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
Lasso di tempo: Baseline, 12 months
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FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week.
FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms.
Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression.
Total scores range from 0-80; Higher score=greater negative impact.
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Baseline, 12 months
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Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
Lasso di tempo: Baseline, 12 months
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The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life.
Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.
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Baseline, 12 months
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Number of Outpatient Visits Due to Fibromyalgia (FM)
Lasso di tempo: Baseline through 12 months
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Baseline through 12 months
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Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Lasso di tempo: Baseline through 12 months
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Baseline through 12 months
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Number of Days of Partial Care for Fibromyalgia (FM) Participants
Lasso di tempo: Baseline through 12 months
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Partial (day or night) care included day care, day nursing home, and partial hospitalization.
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Baseline through 12 months
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Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Lasso di tempo: Baseline through 12 months
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Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.
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Baseline through 12 months
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Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Lasso di tempo: Baseline through 12 months
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Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.
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Baseline through 12 months
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Lasso di tempo: Baseline through 12 months
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Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.
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Baseline through 12 months
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Lasso di tempo: Baseline through 12 months
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Participant productivity was described as the number of days a participant missed work due to FM.
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Baseline through 12 months
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11540
- F1J-MC-B020 (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Treatment for Fibromyalgia
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National Institute on Aging (NIA)SconosciutoDemenza | Problemi di comportamentoStati Uniti
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University of Illinois at ChicagoNational Institute on Aging (NIA)ReclutamentoMalattie cardiache (malattia coronarica, cardiopatia ischemica, cardiopatia ipertensiva) | Diabete non controllato (HBA1c ≥ 10)Stati Uniti
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Reistone Biopharma Company LimitedCompletato
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Hill-RomCompletato
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Forendo Pharma LtdRichmond Pharmacology LimitedCompletatoBiodisponibilità relativaRegno Unito
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Attivo, non reclutante
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Universidad Miguel Hernandez de ElcheAttivo, non reclutanteDisordine depressivo | Disturbi dell'umore | Disturbi d'ansia | Disturbo emotivo | Sintomi depressivi | Disturbi e sintomi d'ansiaSpagna
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Ohio State UniversityReclutamentoGenitorialità | Disturbi mentali nell'adolescenza | Adolescente - Problema emotivoStati Uniti
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Forendo Pharma LtdRichmond Pharmacology LimitedCompletato
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University of GlasgowCompletatoMorbo di Crohn | Modifica dieteticaRegno Unito