A Study for Patient With Chronic Low Back Pain
30 de septiembre de 2010 actualizado por: Eli Lilly and Company
Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
401
Fase
- Fase 3
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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Aalen, Alemania, 73430
- 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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Alzenau, Alemania, 63755
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Berlin, Alemania, 10629
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Ellwangen, Alemania, 73479
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Hamburg, Alemania, 20255
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Wiesbaden, Alemania, 65189
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Sa Coma, Brasil, 04230000
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São Paulo, Brasil, 04026-000
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Barcelona, España, 08025
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Bilboa, España, 48013
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Getafe, España, 28905
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La Coruña, España, 15006
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Madrid, España, 28009
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Arizona
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Chandler, Arizona, Estados Unidos, 85225
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Connecticut
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Cromwell, Connecticut, Estados Unidos, 06416
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Florida
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Deland, Florida, Estados Unidos, 32720
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Jacksonville, Florida, Estados Unidos, 32216
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Massachusetts
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Brighton, Massachusetts, Estados Unidos, 02135
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73109
- 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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Oregon
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Portland, Oregon, Estados Unidos, 97210
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Moscow, Federación Rusa, 119992
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Rotterdam, Países Bajos, 3039 BD
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Krakow, Polonia, 30-349
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Lublin, Polonia, 20-093
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Poznan, Polonia, 61-289
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Szczecin, Polonia, 70-376
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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
Descripción
Inclusion Criteria:
- Male or female outpatients with chronic low back pain
Exclusion Criteria:
- Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
- Daily use of narcotics.
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Duloxetine
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
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60 mg orally once daily for 12 weeks
Otros nombres:
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Comparador de placebos: Placebo
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
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Placebo once daily orally for 12 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
Periodo de tiempo: baseline, 12 weeks
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A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
Periodo de tiempo: baseline, 12 weeks
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BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function.
Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now.
Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in 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 weeks
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Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
Periodo de tiempo: baseline, 12 weeks
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24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Patients completed the electronic diary at bedtime.
The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means.
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Periodo de tiempo: 12 weeks
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Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score.
BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Response was assessed at endpoint.
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12 weeks
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Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Periodo de tiempo: 12 weeks
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Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score.
BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Response was assessed at endpoint.
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12 weeks
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Number of Sustained Responders at 12 Week Endpoint
Periodo de tiempo: 12 weeks
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Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit.
BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Number of sustained responders was assessed at endpoint.
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12 weeks
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Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
Periodo de tiempo: 12 weeks
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The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction.
The thresholds are given as percent reductions in BPI average pain score from the baseline score.
BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Number of participants under each threshold was assessed at endpoint.
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12 weeks
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Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)
Periodo de tiempo: baseline, 12 weeks
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Measures severity of illness at the time of assessment compared with start of treatment.
Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Patient's Global Impression of Improvement (PGI-I) at 12 Weeks
Periodo de tiempo: 12 weeks
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A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment.
The score ranges from 1 (very much better) to 7 (very much worse).
Least Squares Mean values were controlled for investigator and baseline severity.
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12 weeks
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Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire
Periodo de tiempo: baseline, 12 weeks
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Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain.
The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement.
The number of statements marked will be added up by the clinician and a total score is given.
The total score ranges from 0 (no disability) to 24 (severe disability).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Periodo de tiempo: baseline, 12 weeks
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The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig).
Item scores: 0 (not at all) to 4 (extremely).
Each factor scores range from 0 to 20.
The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Periodo de tiempo: baseline, 12 weeks
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The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]).
The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
Periodo de tiempo: baseline, 12 weeks
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Generic, multidimensional, health-related, quality-of-life instrument.
The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood.
A single score between 1 and 3 is generated for each domain.
For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm.
The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient.
Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Periodo de tiempo: baseline, 12 weeks
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WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
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baseline, 12 weeks
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Participants Who Discontinued From Baseline to 12 Weeks
Periodo de tiempo: baseline, 12 weeks
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Reasons for discontinuation are listed in the participant flow.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Uric Acid
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Albumin
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Creatinine
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Total Protein
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Blood Pressure
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Weight
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Pulse Rate
Periodo de tiempo: baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale
Periodo de tiempo: baseline through 12 weeks
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The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period.
The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
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baseline through 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15.
- Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.
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 septiembre de 2008
Finalización primaria (Actual)
1 de julio de 2009
Finalización del estudio (Actual)
1 de julio de 2009
Fechas de registro del estudio
Enviado por primera vez
3 de octubre de 2008
Primero enviado que cumplió con los criterios de control de calidad
6 de octubre de 2008
Publicado por primera vez (Estimar)
7 de octubre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de octubre de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
30 de septiembre de 2010
Última verificación
1 de septiembre de 2010
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Dolor de espalda
- Lumbalgia
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Agentes de dopamina
- Inhibidores de la recaptación de serotonina y noradrenalina
- Clorhidrato de duloxetina
Otros números de identificación del estudio
- 12360
- F1J-MC-HMGC (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .