Longitudinal Study of Patients With Opioid-Induced Constipation



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:October 2012
End Date:December 2014

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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.


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
We found this trial at
25
sites
South Miami, Florida
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South Miami, FL
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4720 S. Western Avenue
Oklahoma City, Oklahoma 73109
405-634-5529
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Oklahoma City, OK
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Artelia, California
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Artelia, CA
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Atco, New Jersey 08004
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Atco, NJ
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Beavercreek, Ohio 45432
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Beavercreek, OH
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Birmingham, Alabama 35215
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Birmingham, AL
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Calgary, Alberta
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Calgary,
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Canton, OH
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Charleston, South Carolina 29406
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Charleston, SC
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Charlotte, North Carolina
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Charlotte, NC
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Chicago, Illinois 60657
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Chicago, IL
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Dayton, OH
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El Cajon, California 92020
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El Cajon, CA
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Jacksonville, Florida 32216
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Jacksonville, FL
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Laguna Hills, California
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Laguna Hills, CA
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Lajuna Hills, California
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Lajuna Hills, CA
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Los Gatos, California 95032
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Los Gatos, CA
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Mobile, Alabama 36608
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Mobile, AL
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Myrtle Beach, South Carolina 29588
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Myrtle Beach, SC
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Newington, New Hampshire
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Newington, NH
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North Massapequa, NY
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Phoenix, Arizona 85050
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Phoenix, AZ
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Salt Lake City, Utah 84124
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Salt Lake City, UT
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San Diego, California 92115
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San Diego, CA
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Sarasota, Florida 34321
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Sarasota, FL
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