Longitudinal Study of Patients With Opioid-Induced Constipation
NCT ID: NCT01928953
Last Updated: 2015-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
520 participants
OBSERVATIONAL
2012-10-31
2014-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* (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 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
18 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Sostek, M.D.
Role: STUDY_DIRECTOR
AstraZeneca
Cathy Datto, M.D., M.S.
Role: STUDY_DIRECTOR
AstraZeneca
Robert J LoCasale, Phd, MS
Role: PRINCIPAL_INVESTIGATOR
AstraZeneca
Locations
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Alliance Clinical Research
Birmingham, Alabama, United States
Horizon Research Group, Inc
Mobile, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
Advanced Rx Clinical Research
Artelia, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Akkiance Research Centers
Laguna Hills, California, United States
Primecare Clinical Research
Lajuna Hills, California, United States
Samaritan Center for Medical Research
Los Gatos, California, United States
Precision Research Institute, LLC
San Diego, California, United States
Southeast Clinical Research, LLC
Jacksonville, Florida, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, United States
Soth Miami Clinical Research
South Miami, Florida, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States
ActivMed Practices & Research
Newington, New Hampshire, United States
Atco Medical Associates, P.C.
Atco, New Jersey, United States
DiGiovanna Institute for medical Education and Research
North Massapequa, New York, United States
Gaffnew Health Services
Charlotte, North Carolina, United States
Clinical Inquest Center LTD
Beavercreek, Ohio, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, United States
Clinical Inquest Center, Ltd.
Dayton, Ohio, United States
NPC Research
Oklahoma City, Oklahoma, United States
Pain Research of Charleston
Charleston, South Carolina, United States
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, United States
Highland Clinical Research
Salt Lake City, Utah, United States
University of Calgary
Calgary, Alberta, Canada
Paradise Medical Clinic
Paradise, Newfoundland and Labrador, Canada
Aviva Clinical Trial Group Inc.
Burlington, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
Taunton Health Centre
Oshawa, Ontario, Canada
Pro-Recherche
Saint Romuald, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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12AST11894/A-12292
Identifier Type: -
Identifier Source: org_study_id
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