Longitudinal Study of Patients With Opioid-Induced Constipation
7 juillet 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
520
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alberta
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Calgary, Alberta, Canada
- University of Calgary
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Newfoundland and Labrador
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Paradise, Newfoundland and Labrador, Canada
- Paradise Medical Clinic
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Ontario
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Burlington, Ontario, Canada
- Aviva Clinical Trial Group Inc.
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Newmarket, Ontario, Canada
- SKDS Research Inc.
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Oshawa, Ontario, Canada
- Taunton Health Centre
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Quebec
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St. Romuald, Quebec, Canada
- Pro-Recherche
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Alabama
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Birmingham, Alabama, États-Unis
- Alliance Clinical Research
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Mobile, Alabama, États-Unis
- Horizon Research Group, Inc
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Arizona
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Phoenix, Arizona, États-Unis
- HOPE Research Institute
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California
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Artelia, California, États-Unis
- Advanced Rx Clinical Research
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El Cajon, California, États-Unis
- TriWest Research Associates, LLC
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Laguna Hills, California, États-Unis
- Akkiance Research Centers
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Lajuna Hills, California, États-Unis
- Primecare Clinical Research
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Los Gatos, California, États-Unis
- Samaritan Center for Medical Research
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San Diego, California, États-Unis
- Precision Research Institute, LLC
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Florida
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Jacksonville, Florida, États-Unis
- Southeast Clinical Research, LLC
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Sarasota, Florida, États-Unis
- Physician Care Clinical Research, LLC
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South Miami, Florida, États-Unis
- Soth Miami Clinical Research
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Illinois
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Chicago, Illinois, États-Unis
- Chicago Anesthesia Pain Specialists
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New Hampshire
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Newington, New Hampshire, États-Unis
- ActivMed Practices & Research
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New Jersey
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Atco, New Jersey, États-Unis
- Atco Medical Associates, P.C.
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New York
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North Massapequa, New York, États-Unis
- DiGiovanna Institute for Medical Education And Research
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North Carolina
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Charlotte, North Carolina, États-Unis
- Gaffnew Health Services
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Ohio
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Beavercreek, Ohio, États-Unis
- Clinical Inquest Center Ltd
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Canton, Ohio, États-Unis
- Ohio Clinical Research Partners, LLC
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Dayton, Ohio, États-Unis
- Clinical Inquest Center, Ltd.
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis
- NPC Research
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South Carolina
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Charleston, South Carolina, États-Unis
- Pain Research of Charleston
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Myrtle Beach, South Carolina, États-Unis
- Family Medicine of Sayebrook
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Utah
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Salt Lake City, Utah, États-Unis
- Highland Clinical Research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Rate of LIR among the OIC population
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).
Délai: 6 months
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6 months
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Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).
Délai: 12months retrospectively
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12months retrospectively
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Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.
Délai: 6 months
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6 months
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Healthcare resource utilization profiles pre- and post-baseline
Délai: 6 months
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6 months
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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.
Délai: 6 months
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6 months
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Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions).
Délai: 6 months
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6 months
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Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL).
Délai: 6 months
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6 months
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Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.
Délai: 6 months
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6 months
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Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period
Délai: 6 months
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6 months
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Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives.
Délai: 6 months
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6 months
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Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Mark Sostek, M.D., AstraZeneca
- Directeur d'études: Cathy Datto, M.D., M.S., AstraZeneca
- Chercheur principal: Robert J LoCasale, Phd, MS, AstraZeneca
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2012
Achèvement primaire (Réel)
1 décembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
22 août 2013
Première soumission répondant aux critères de contrôle qualité
22 août 2013
Première publication (Estimation)
27 août 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 juillet 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 juillet 2015
Dernière vérification
1 juillet 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12AST11894/A-12292
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .