Longitudinal Study of Patients With Opioid-Induced Constipation

Completed

Conditions studied: Patients With Opioid Induced Constipation

In brief

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.

Key facts

Study ID

NCT01928953

Run by

AstraZeneca

People needed

520

Starts

2012-10-01

Expected to finish

2014-12-01

Last updated by the study team

2015-07-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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