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Longitudinal Study of Patients With Opioid-Induced Constipation

7. juli 2015 opdateret af: 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:

  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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

520

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

22. august 2013

Først indsendt, der opfyldte QC-kriterier

22. august 2013

Først opslået (Skøn)

27. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12AST11894/A-12292

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Patients With Opioid Induced Constipation

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner