Clinical trial NCT01928953: Longitudinal Study of Patients With Opioid-Induced Constipation
Official title: Longitudinal Study of Patients With Opioid-Induced Constipation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Opioid Induced Constipation
Keywords: opioid induced constipation in patients without cancer and with cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population consists of patients who have been on daily opioid therapy for ≥ 4 weeks for the treatment of chronic non-cancer or cancer pain and who have opioid-induced constipation, as per patient history.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of LIR among the OIC population
timeFrame: 6 months
Secondary outcomes:
measure: Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).
timeFrame: 6 months
measure: Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).
timeFrame: 12months retrospectively
measure: Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.
timeFrame: 6 months
measure: Healthcare resource utilization profiles pre- and post-baseline
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions).
timeFrame: 6 months
measure: Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL).
timeFrame: 6 months
measure: Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.
timeFrame: 6 months
measure: Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period
timeFrame: 6 months
measure: Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives.
timeFrame: 6 months
measure: Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Artelia
country: United States
facility: Advanced Rx Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Laguna Hills
country: United States
facility: Akkiance Research Centers
state: California
city: Lajuna Hills
country: United States
facility: Primecare Clinical Research
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: Jacksonville
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Soth Miami Clinical Research
state: Florida
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Newington
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: Atco
country: United States
facility: Atco Medical Associates, P.C.
state: New Jersey
city: North Massapequa
country: United States
facility: DiGiovanna Institute for medical Education and Research
state: New York
city: Charlotte
country: United States
facility: Gaffnew Health Services
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center LTD
state: Ohio
city: Canton
country: United States
facility: Ohio Clinical Research Partners, LLC
state: Ohio
city: Dayton
country: United States
facility: Clinical Inquest Center, Ltd.
state: Ohio
city: Oklahoma City
country: United States
facility: NPC Research
state: Oklahoma
city: Charleston
country: United States
facility: Pain Research of Charleston
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook
state: South Carolina
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Paradise
country: Canada
facility: Paradise Medical Clinic
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Aviva Clinical Trial Group Inc.
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: St. Romuald
country: Canada
facility: Pro-Recherche
state: Quebec
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, M.D.
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Cathy Datto, M.D., M.S.
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Robert J LoCasale, Phd, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.