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Longitudinal Study of Patients With Opioid-Induced Constipation

7 juli 2015 bijgewerkt door: AstraZeneca

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:

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;
To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC;
To describe drug utilization and self-management of OIC;
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;
To describe patient-reported impact of OIC on health-related quality of life, productivity, and pain management;
To describe patient-reported treatment satisfaction with laxative use; and
To describe physician-reported awareness of OIC and symptoms and understanding of patient-reported impact of OIC.

Studie Overzicht

Toestand

Voltooid

Conditie

Patients With Opioid Induced Constipation

Studietype

Observationeel

Inschrijving (Werkelijk)

520

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Canada
- Alberta
  - Calgary, Alberta, Canada
    - University Of Calgary
- Newfoundland and Labrador
  - Paradise, Newfoundland and Labrador, Canada
    - Paradise Medical Clinic
- Ontario
  - Burlington, Ontario, Canada
    - Aviva Clinical Trial Group Inc.
  - Newmarket, Ontario, Canada
    - SKDS Research Inc.
  - Oshawa, Ontario, Canada
    - Taunton Health Centre
- Quebec
  - St. Romuald, Quebec, Canada
    - Pro-Recherche
Verenigde Staten
- Alabama
  - Birmingham, Alabama, Verenigde Staten
    - Alliance Clinical Research
  - Mobile, Alabama, Verenigde Staten
    - Horizon Research Group, Inc
- Arizona
  - Phoenix, Arizona, Verenigde Staten
    - HOPE Research Institute
- California
  - Artelia, California, Verenigde Staten
    - Advanced Rx Clinical Research
  - El Cajon, California, Verenigde Staten
    - TriWest Research Associates, LLC
  - Laguna Hills, California, Verenigde Staten
    - Akkiance Research Centers
  - Lajuna Hills, California, Verenigde Staten
    - Primecare Clinical Research
  - Los Gatos, California, Verenigde Staten
    - Samaritan Center for Medical Research
  - San Diego, California, Verenigde Staten
    - Precision Research Institute, LLC
- Florida
  - Jacksonville, Florida, Verenigde Staten
    - Southeast Clinical Research, LLC
  - Sarasota, Florida, Verenigde Staten
    - Physician Care Clinical Research, LLC
  - South Miami, Florida, Verenigde Staten
    - Soth Miami Clinical Research
- Illinois
  - Chicago, Illinois, Verenigde Staten
    - Chicago Anesthesia Pain Specialists
- New Hampshire
  - Newington, New Hampshire, Verenigde Staten
    - ActivMed Practices & Research
- New Jersey
  - Atco, New Jersey, Verenigde Staten
    - Atco Medical Associates, P.C.
- New York
  - North Massapequa, New York, Verenigde Staten
    - DiGiovanna Institute for Medical Education and Research
- North Carolina
  - Charlotte, North Carolina, Verenigde Staten
    - Gaffnew Health Services
- Ohio
  - Beavercreek, Ohio, Verenigde Staten
    - Clinical Inquest Center Ltd
  - Canton, Ohio, Verenigde Staten
    - Ohio Clinical Research Partners, LLC
  - Dayton, Ohio, Verenigde Staten
    - Clinical Inquest Center, Ltd.
- Oklahoma
  - Oklahoma City, Oklahoma, Verenigde Staten
    - NPC Research
- South Carolina
  - Charleston, South Carolina, Verenigde Staten
    - Pain Research of Charleston
  - Myrtle Beach, South Carolina, Verenigde Staten
    - Family Medicine of Sayebrook
- Utah
  - Salt Lake City, Utah, Verenigde Staten
    - Highland Clinical Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Rate of LIR among the OIC population Tijdsspanne: 6 months	6 months

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR). Tijdsspanne: 6 months	6 months
Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications). Tijdsspanne: 12months retrospectively	12months retrospectively
Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period. Tijdsspanne: 6 months	6 months
Healthcare resource utilization profiles pre- and post-baseline Tijdsspanne: 6 months	6 months
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. Tijdsspanne: 6 months	6 months
Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions). Tijdsspanne: 6 months	6 months
Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL). Tijdsspanne: 6 months	6 months
Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period. Tijdsspanne: 6 months	6 months
Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period Tijdsspanne: 6 months	6 months
Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives. Tijdsspanne: 6 months	6 months
Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline. Tijdsspanne: 6 months	6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

Studie directeur: Mark Sostek, M.D., AstraZeneca
Studie directeur: Cathy Datto, M.D., M.S., AstraZeneca
Hoofdonderzoeker: Robert J LoCasale, Phd, MS, AstraZeneca

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Werkelijk)

1 december 2014

Studie voltooiing (Werkelijk)