此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Longitudinal Study of Patients With Opioid-Induced Constipation

2015年7月7日 更新者：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:

  1. 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;
  2. To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC;
  3. To describe drug utilization and self-management of OIC;
  4. 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;
  5. To describe patient-reported impact of OIC on health-related quality of life, productivity, and pain management;
  6. To describe patient-reported treatment satisfaction with laxative use; and
  7. To describe physician-reported awareness of OIC and symptoms and understanding of patient-reported impact of OIC.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

520

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Rate of LIR among the OIC population
大体时间：6 months
6 months

次要结果测量

结果测量
大体时间
Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).
大体时间：6 months
6 months
Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).
大体时间：12months retrospectively
12months retrospectively
Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.
大体时间：6 months
6 months
Healthcare resource utilization profiles pre- and post-baseline
大体时间：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.
大体时间：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).
大体时间：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).
大体时间：6 months
6 months
Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.
大体时间：6 months
6 months
Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period
大体时间：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.
大体时间：6 months
6 months
Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.
大体时间：6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

调查人员

  • 研究主任：Mark Sostek, M.D.、AstraZeneca
  • 研究主任：Cathy Datto, M.D., M.S.、AstraZeneca
  • 首席研究员：Robert J LoCasale, Phd, MS、AstraZeneca

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2013年8月22日

首先提交符合 QC 标准的

2013年8月22日

首次发布 (估计)

2013年8月27日

研究记录更新

最后更新发布 (估计)

2015年7月8日

上次提交的符合 QC 标准的更新

2015年7月7日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12AST11894/A-12292

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅