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Longitudinal Study of Patients With Opioid-Induced Constipation

7. juli 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Patients With Opioid Induced Constipation

Studietype

Observasjonsmessig

Registrering (Faktiske)

520

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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
Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater
    - Alliance Clinical Research
  - Mobile, Alabama, Forente stater
    - Horizon Research Group, Inc
- Arizona
  - Phoenix, Arizona, Forente stater
    - HOPE Research Institute
- California
  - Artelia, California, Forente stater
    - Advanced Rx Clinical Research
  - El Cajon, California, Forente stater
    - TriWest Research Associates, LLC
  - Laguna Hills, California, Forente stater
    - Akkiance Research Centers
  - Lajuna Hills, California, Forente stater
    - Primecare Clinical Research
  - Los Gatos, California, Forente stater
    - Samaritan Center for Medical Research
  - San Diego, California, Forente stater
    - Precision Research Institute, LLC
- Florida
  - Jacksonville, Florida, Forente stater
    - Southeast Clinical Research, LLC
  - Sarasota, Florida, Forente stater
    - Physician Care Clinical Research, LLC
  - South Miami, Florida, Forente stater
    - Soth Miami Clinical Research
- Illinois
  - Chicago, Illinois, Forente stater
    - Chicago Anesthesia Pain Specialists
- New Hampshire
  - Newington, New Hampshire, Forente stater
    - ActivMed Practices & Research
- New Jersey
  - Atco, New Jersey, Forente stater
    - Atco Medical Associates, P.C.
- New York
  - North Massapequa, New York, Forente stater
    - DiGiovanna Institute for Medical Education and Research
- North Carolina
  - Charlotte, North Carolina, Forente stater
    - Gaffnew Health Services
- Ohio
  - Beavercreek, Ohio, Forente stater
    - Clinical Inquest Center Ltd
  - Canton, Ohio, Forente stater
    - Ohio Clinical Research Partners, LLC
  - Dayton, Ohio, Forente stater
    - Clinical Inquest Center, Ltd.
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater
    - NPC Research
- South Carolina
  - Charleston, South Carolina, Forente stater
    - Pain Research of Charleston
  - Myrtle Beach, South Carolina, Forente stater
    - Family Medicine of Sayebrook
- Utah
  - Salt Lake City, Utah, Forente stater
    - Highland Clinical Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Rate of LIR among the OIC population Tidsramme: 6 months	6 months

Sekundære resultatmål

Resultatmål	Tidsramme
Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR). Tidsramme: 6 months	6 months
Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications). Tidsramme: 12months retrospectively	12months retrospectively
Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period. Tidsramme: 6 months	6 months
Healthcare resource utilization profiles pre- and post-baseline Tidsramme: 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. Tidsramme: 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). Tidsramme: 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). Tidsramme: 6 months	6 months
Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period. Tidsramme: 6 months	6 months
Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period Tidsramme: 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. Tidsramme: 6 months	6 months
Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline. Tidsramme: 6 months	6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Etterforskere

Studieleder: Mark Sostek, M.D., AstraZeneca
Studieleder: Cathy Datto, M.D., M.S., AstraZeneca
Hovedetterforsker: Robert J LoCasale, Phd, MS, AstraZeneca

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)