Longitudinal Study of Patients With Opioid-Induced Constipation
7 de julio de 2015 actualizado por: AstraZeneca
This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive understanding of the burden of opioid-induced constipation (OIC) in these countries, this study used a combination of web-based, longitudinal patient survey, retrospective data abstraction from medical records, and a prospective physician survey.
The primary objective of this study was to estimate the rate of inadequate response to laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative use ≥ four times per reference period), and inadequate response (defined as fewer than three bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too hard, straining to have a BM, feeling like you didn't "finish" a BM, and feeling like you had to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately) participants with OIC, by country and overall.
The secondary study objectives are as follows:
- To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined as the use of at least two laxative agents, each used ≥ 4 times in the reference period;
- To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC;
- To describe drug utilization and self-management of OIC;
- To describe the pre-index and post-index healthcare resource utilization and estimate costs associated with the diagnosis, treatment, and general management of OIC (including laxative use) and events attributed to OIC, including both direct and indirect costs;
- To describe patient-reported impact of OIC on health-related quality of life, productivity, and pain management;
- To describe patient-reported treatment satisfaction with laxative use; and
- To describe physician-reported awareness of OIC and symptoms and understanding of patient-reported impact of OIC.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
520
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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Alberta
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Calgary, Alberta, Canadá
- University of Calgary
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Newfoundland and Labrador
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Paradise, Newfoundland and Labrador, Canadá
- Paradise Medical Clinic
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Ontario
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Burlington, Ontario, Canadá
- Aviva Clinical Trial Group Inc.
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Newmarket, Ontario, Canadá
- SKDS Research Inc.
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Oshawa, Ontario, Canadá
- Taunton Health Centre
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Quebec
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St. Romuald, Quebec, Canadá
- Pro-Recherche
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Alabama
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Birmingham, Alabama, Estados Unidos
- Alliance Clinical Research
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Mobile, Alabama, Estados Unidos
- Horizon Research Group, Inc
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Arizona
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Phoenix, Arizona, Estados Unidos
- Hope Research Institute
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California
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Artelia, California, Estados Unidos
- Advanced Rx Clinical Research
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El Cajon, California, Estados Unidos
- TriWest Research Associates, LLC
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Laguna Hills, California, Estados Unidos
- Akkiance Research Centers
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Lajuna Hills, California, Estados Unidos
- Primecare Clinical Research
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Los Gatos, California, Estados Unidos
- Samaritan Center for Medical Research
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San Diego, California, Estados Unidos
- Precision Research Institute, LLC
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Florida
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Jacksonville, Florida, Estados Unidos
- Southeast Clinical Research, LLC
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Sarasota, Florida, Estados Unidos
- Physician Care Clinical Research, LLC
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South Miami, Florida, Estados Unidos
- Soth Miami Clinical Research
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Illinois
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Chicago, Illinois, Estados Unidos
- Chicago Anesthesia Pain Specialists
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New Hampshire
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Newington, New Hampshire, Estados Unidos
- ActivMed Practices & Research
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New Jersey
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Atco, New Jersey, Estados Unidos
- Atco Medical Associates, P.C.
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New York
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North Massapequa, New York, Estados Unidos
- DiGiovanna Institute for Medical Education and Research
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North Carolina
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Charlotte, North Carolina, Estados Unidos
- Gaffnew Health Services
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Ohio
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Beavercreek, Ohio, Estados Unidos
- Clinical Inquest Center Ltd
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Canton, Ohio, Estados Unidos
- Ohio Clinical Research Partners, LLC
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Dayton, Ohio, Estados Unidos
- Clinical Inquest Center, Ltd.
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
- NPC Research
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South Carolina
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Charleston, South Carolina, Estados Unidos
- Pain Research of Charleston
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Myrtle Beach, South Carolina, Estados Unidos
- Family Medicine of Sayebrook
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Utah
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Salt Lake City, Utah, Estados Unidos
- Highland Clinical Research
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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 a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
The target population consists of patients who have been on daily opioid therapy for ≥ 4 weeks for the treatment of chronic non-cancer or cancer pain and who have opioid-induced constipation, as per patient history.
Descripción
Inclusion Criteria:
Patient is receiving a minimum total daily dose of 30 mg of oral morphine, or equianalgesic amount[s] of 1 or more other opioid therapies, for a minimum of 4 weeks for chronic pain or cancer relate pain Presence of OIC in the past 2 weeks
- (for cancer patients only) Patient has a current diagnosis of cancer that is not currently in remission and has cancer-related pain Internet access and is able and willing to complete a longitudinal web-based survey
- Patient is able to understand and comply with the requirements of the study, as judged by the investigator (includes ability to read and write and to use
Exclusion Criteria:
Patient is unable or refuses to provide informed consent;
- Patient does not have access to a computer with internet connectivity, or is unable to use a computer to complete the web-based survey; Based on clinical judgment, patient has a history of chronic constipation (i.e. clinical diagnosis, note in the medical record, or patient history);
- Patient has a history of (or current) colon cancer (primary or metastatic) (i.e., clinical diagnosis Patient has received an investigational medication to treat constipation or participated in any study involving investigational compound naloxegol within ≤90 days prior to the baseline visit
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of LIR among the OIC population
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).
Periodo de tiempo: 6 months
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6 months
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Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).
Periodo de tiempo: 12months retrospectively
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12months retrospectively
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Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.
Periodo de tiempo: 6 months
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6 months
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Healthcare resource utilization profiles pre- and post-baseline
Periodo de tiempo: 6 months
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6 months
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Cost of illness related to the diagnosis, treatment, and general management of OIC (including laxative use) and events attributed to OIC, including both direct and indirect costs.
Periodo de tiempo: 6 months
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6 months
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Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions).
Periodo de tiempo: 6 months
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6 months
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Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL).
Periodo de tiempo: 6 months
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6 months
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Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.
Periodo de tiempo: 6 months
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6 months
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Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period
Periodo de tiempo: 6 months
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6 months
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Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives.
Periodo de tiempo: 6 months
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6 months
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Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mark Sostek, M.D., AstraZeneca
- Director de estudio: Cathy Datto, M.D., M.S., AstraZeneca
- Investigador principal: Robert J LoCasale, Phd, MS, AstraZeneca
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
- Gupta A, Coyne KS, Datto C, Venuti C. The Burden of Opioid-Induced Constipation in Younger Patients with Chronic Noncancer Pain. Pain Med. 2018 Dec 1;19(12):2459-2468. doi: 10.1093/pm/pny002.
- LoCasale RJ, Datto C, Wilson H, Yeomans K, Coyne KS. The Burden of Opioid-Induced Constipation: Discordance Between Patient and Health Care Provider Reports. J Manag Care Spec Pharm. 2016 Mar;22(3):236-45. doi: 10.18553/jmcp.2016.22.3.236.
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 octubre de 2012
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
22 de agosto de 2013
Primero enviado que cumplió con los criterios de control de calidad
22 de agosto de 2013
Publicado por primera vez (Estimar)
27 de agosto de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12AST11894/A-12292
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. .