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Longitudinal Study of Patients With Opioid-Induced Constipation

7 de julho de 2015 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Patients With Opioid Induced Constipation

Tipo de estudo

Observacional

Inscrição (Real)

520

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Canadá
- Alberta
  - Calgary, Alberta, Canadá
    - University of Calgary
- Newfoundland and Labrador
  - Paradise, Newfoundland and Labrador, Canadá
    - Paradise Medical Clinic
- Ontario
  - Burlington, Ontario, Canadá
    - Aviva Clinical Trial Group Inc.
  - Newmarket, Ontario, Canadá
    - SKDS Research Inc.
  - Oshawa, Ontario, Canadá
    - Taunton Health Centre
- Quebec
  - St. Romuald, Quebec, Canadá
    - Pro-Recherche
Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos
    - Alliance Clinical Research
  - Mobile, Alabama, Estados Unidos
    - Horizon Research Group, Inc
- Arizona
  - Phoenix, Arizona, Estados Unidos
    - Hope Research Institute
- California
  - Artelia, California, Estados Unidos
    - Advanced Rx Clinical Research
  - El Cajon, California, Estados Unidos
    - TriWest Research Associates, LLC
  - Laguna Hills, California, Estados Unidos
    - Akkiance Research Centers
  - Lajuna Hills, California, Estados Unidos
    - Primecare Clinical Research
  - Los Gatos, California, Estados Unidos
    - Samaritan Center for Medical Research
  - San Diego, California, Estados Unidos
    - Precision Research Institute, LLC
- Florida
  - Jacksonville, Florida, Estados Unidos
    - Southeast Clinical Research, LLC
  - Sarasota, Florida, Estados Unidos
    - Physician Care Clinical Research, LLC
  - South Miami, Florida, Estados Unidos
    - Soth Miami Clinical Research
- Illinois
  - Chicago, Illinois, Estados Unidos
    - Chicago Anesthesia Pain Specialists
- New Hampshire
  - Newington, New Hampshire, Estados Unidos
    - ActivMed Practices & Research
- New Jersey
  - Atco, New Jersey, Estados Unidos
    - Atco Medical Associates, P.C.
- New York
  - North Massapequa, New York, Estados Unidos
    - DiGiovanna Institute for Medical Education and Research
- North Carolina
  - Charlotte, North Carolina, Estados Unidos
    - Gaffnew Health Services
- Ohio
  - Beavercreek, Ohio, Estados Unidos
    - Clinical Inquest Center Ltd
  - Canton, Ohio, Estados Unidos
    - Ohio Clinical Research Partners, LLC
  - Dayton, Ohio, Estados Unidos
    - Clinical Inquest Center, Ltd.
- Oklahoma
  - Oklahoma City, Oklahoma, Estados Unidos
    - NPC Research
- South Carolina
  - Charleston, South Carolina, Estados Unidos
    - Pain Research of Charleston
  - Myrtle Beach, South Carolina, Estados Unidos
    - Family Medicine of Sayebrook
- Utah
  - Salt Lake City, Utah, Estados Unidos
    - Highland Clinical Research

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Prazo
Rate of LIR among the OIC population Prazo: 6 months	6 months

Medidas de resultados secundários

Medida de resultado	Prazo
Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR). Prazo: 6 months	6 months
Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications). Prazo: 12months retrospectively	12months retrospectively
Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period. Prazo: 6 months	6 months
Healthcare resource utilization profiles pre- and post-baseline Prazo: 6 months	6 months
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. Prazo: 6 months	6 months
Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions). Prazo: 6 months	6 months
Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL). Prazo: 6 months	6 months
Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period. Prazo: 6 months	6 months
Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period Prazo: 6 months	6 months
Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives. Prazo: 6 months	6 months
Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline. Prazo: 6 months	6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Investigadores

Diretor de estudo: Mark Sostek, M.D., AstraZeneca
Diretor de estudo: Cathy Datto, M.D., M.S., AstraZeneca
Investigador principal: Robert J LoCasale, Phd, MS, AstraZeneca

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2012

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)