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.
| Status | Completed |
| Enrollment | 520 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Aviva Clinical Trial Group Inc. | Burlington | Ontario |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | SKDS Research Inc. | Newmarket | Ontario |
| Canada | Taunton Health Centre | Oshawa | Ontario |
| Canada | Paradise Medical Clinic | Paradise | Newfoundland and Labrador |
| Canada | Pro-Recherche | St. Romuald | Quebec |
| United States | Advanced Rx Clinical Research | Artelia | California |
| United States | Atco Medical Associates, P.C. | Atco | New Jersey |
| United States | Clinical Inquest Center LTD | Beavercreek | Ohio |
| United States | Alliance Clinical Research | Birmingham | Alabama |
| United States | Ohio Clinical Research Partners, LLC | Canton | Ohio |
| United States | Pain Research of Charleston | Charleston | South Carolina |
| United States | Gaffnew Health Services | Charlotte | North Carolina |
| United States | Chicago Anesthesia Pain Specialists | Chicago | Illinois |
| United States | Clinical Inquest Center, Ltd. | Dayton | Ohio |
| United States | TriWest Research Associates, LLC | El Cajon | California |
| United States | Southeast Clinical Research, LLC | Jacksonville | Florida |
| 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 | Horizon Research Group, Inc | Mobile | Alabama |
| United States | Family Medicine of SayeBrook | Myrtle Beach | South Carolina |
| United States | ActivMed Practices & Research | Newington | New Hampshire |
| United States | DiGiovanna Institute for medical Education and Research | North Massapequa | New York |
| United States | NPC Research | Oklahoma City | Oklahoma |
| United States | HOPE Research Institute | Phoenix | Arizona |
| United States | Highland Clinical Research | Salt Lake City | Utah |
| United States | Precision Research Institute, LLC | San Diego | California |
| United States | Physician Care Clinical Research, LLC | Sarasota | Florida |
| United States | Soth Miami Clinical Research | South Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of LIR among the OIC population | 6 months | No | |
| Secondary | Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR). | 6 months | No | |
| Secondary | Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications). | 12months retrospectively | No | |
| Secondary | Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period. | 6 months | No | |
| Secondary | Healthcare resource utilization profiles pre- and post-baseline | 6 months | No | |
| Secondary | 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. | 6 months | No | |
| Secondary | Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions). | 6 months | No | |
| Secondary | Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL). | 6 months | No | |
| Secondary | Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period. | 6 months | No | |
| Secondary | Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period | 6 months | No | |
| Secondary | Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives. | 6 months | No | |
| Secondary | Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline. | 6 months | No |