Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
29 de noviembre de 2012 actualizado por: Eli Lilly and Company
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
1700
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
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California
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Santa Barbara, California, Estados Unidos, 93108
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
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Waterbury, Connecticut, Estados Unidos, 06708
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20006
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Florida
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Jupiter, Florida, Estados Unidos, 33458
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Tampa, Florida, Estados Unidos, 33609
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Winter Park, Florida, Estados Unidos, 32792
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Georgia
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Blue Ridge, Georgia, Estados Unidos, 30513
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Snellville, Georgia, Estados Unidos, 30078
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
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Nampa, Idaho, Estados Unidos, 83686
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Illinois
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Peoria, Illinois, Estados Unidos, 61614
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Springfield, Illinois, Estados Unidos, 62702
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Indiana
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Evansville, Indiana, Estados Unidos, 47710
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Fishers, Indiana, Estados Unidos, 46038
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Indianapolis, Indiana, Estados Unidos, 46260
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40223
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
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Maryland
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Baltimore, Maryland, Estados Unidos, 21222
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Towson, Maryland, Estados Unidos, 21286
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Wheaton, Maryland, Estados Unidos, 20902
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Michigan
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Lansing, Michigan, Estados Unidos, 48910
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Missouri
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West Plains, Missouri, Estados Unidos, 65775
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Nevada
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Reno, Nevada, Estados Unidos, 89502
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New Jersey
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Dover, New Jersey, Estados Unidos, 07801
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East Brunswick, New Jersey, Estados Unidos, 08816
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Medford, New Jersey, Estados Unidos, 08055
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New York
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Schenectady, New York, Estados Unidos, 12308
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North Carolina
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Boone, North Carolina, Estados Unidos, 28607
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Charlotte, North Carolina, Estados Unidos, 28210
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North Dakota
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Minot, North Dakota, Estados Unidos, 58701
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
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Cleveland, Ohio, Estados Unidos, 44195
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Findlay, Ohio, Estados Unidos, 45840
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
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West Reading, Pennsylvania, Estados Unidos, 19611
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Texas
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Arlington, Texas, Estados Unidos, 76011
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Dallas, Texas, Estados Unidos, 75278
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Flower Mound, Texas, Estados Unidos, 75028
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Garland, Texas, Estados Unidos, 75042
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Grand Prairie, Texas, Estados Unidos, 75050
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Houston, Texas, Estados Unidos, 77034
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Utah
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Salt Lake City, Utah, Estados Unidos, 84102
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
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Washington
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Kirkland, Washington, Estados Unidos, 98034
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Seattle, Washington, Estados Unidos, 98104
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West Virginia
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Beckley, West Virginia, Estados Unidos, 25801
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Cidra, Puerto Rico, 00739
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Hato Rey, Puerto Rico, 00920
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Humacao, Puerto Rico, 00791
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Levittown, Puerto Rico, 00949
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Manati, Puerto Rico, 00674
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Mayaguez, Puerto Rico, 00680
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Rio Piedras, Puerto Rico, 00921
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San German, Puerto Rico, 00683
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Santa Isabel, Puerto Rico, 00757
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Multiple care centers
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2008
Finalización primaria (Actual)
1 de abril de 2011
Finalización del estudio (Actual)
1 de abril de 2011
Fechas de registro del estudio
Enviado por primera vez
28 de julio de 2008
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2008
Publicado por primera vez (Estimar)
30 de julio de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de noviembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
29 de noviembre de 2012
Última verificación
1 de abril de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11540
- F1J-MC-B020 (Otro identificador: Eli Lilly and Company)
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