Patients With Opioid Induced Constipation Clinical Trial
Official title:
Longitudinal Study of Patients With Opioid-Induced Constipation
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective