Longitudinal Study of Patients With Opioid-Induced Constipation
7 luglio 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
520
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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-
-
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Alabama
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Birmingham, Alabama, Stati Uniti
- Alliance Clinical Research
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Mobile, Alabama, Stati Uniti
- Horizon Research Group, Inc
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Arizona
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Phoenix, Arizona, Stati Uniti
- Hope Research Institute
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California
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Artelia, California, Stati Uniti
- Advanced Rx Clinical Research
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El Cajon, California, Stati Uniti
- TriWest Research Associates, LLC
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Laguna Hills, California, Stati Uniti
- Akkiance Research Centers
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Lajuna Hills, California, Stati Uniti
- Primecare Clinical Research
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Los Gatos, California, Stati Uniti
- Samaritan Center for Medical Research
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San Diego, California, Stati Uniti
- Precision Research Institute, LLC
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Florida
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Jacksonville, Florida, Stati Uniti
- Southeast Clinical Research, LLC
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Sarasota, Florida, Stati Uniti
- Physician Care Clinical Research, LLC
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South Miami, Florida, Stati Uniti
- Soth Miami Clinical Research
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Illinois
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Chicago, Illinois, Stati Uniti
- Chicago Anesthesia Pain Specialists
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New Hampshire
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Newington, New Hampshire, Stati Uniti
- ActivMed Practices & Research
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New Jersey
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Atco, New Jersey, Stati Uniti
- Atco Medical Associates, P.C.
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New York
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North Massapequa, New York, Stati Uniti
- DiGiovanna Institute for Medical Education And Research
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North Carolina
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Charlotte, North Carolina, Stati Uniti
- Gaffnew Health Services
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Ohio
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Beavercreek, Ohio, Stati Uniti
- Clinical Inquest Center Ltd
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Canton, Ohio, Stati Uniti
- Ohio Clinical Research Partners, LLC
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Dayton, Ohio, Stati Uniti
- Clinical Inquest Center, Ltd.
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti
- NPC Research
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South Carolina
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Charleston, South Carolina, Stati Uniti
- Pain Research of Charleston
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Myrtle Beach, South Carolina, Stati Uniti
- Family Medicine of Sayebrook
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Utah
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Salt Lake City, Utah, Stati Uniti
- Highland Clinical Research
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Rate of LIR among the OIC population
Lasso di tempo: 6 months
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).
Lasso di tempo: 6 months
|
6 months
|
|
Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).
Lasso di tempo: 12months retrospectively
|
12months retrospectively
|
|
Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.
Lasso di tempo: 6 months
|
6 months
|
|
Healthcare resource utilization profiles pre- and post-baseline
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 6 months
|
6 months
|
|
Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.
Lasso di tempo: 6 months
|
6 months
|
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Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period
Lasso di tempo: 6 months
|
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.
Lasso di tempo: 6 months
|
6 months
|
|
Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Mark Sostek, M.D., AstraZeneca
- Direttore dello studio: Cathy Datto, M.D., M.S., AstraZeneca
- Investigatore principale: Robert J LoCasale, Phd, MS, AstraZeneca
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2012
Completamento primario (Effettivo)
1 dicembre 2014
Completamento dello studio (Effettivo)
1 dicembre 2014
Date di iscrizione allo studio
Primo inviato
22 agosto 2013
Primo inviato che soddisfa i criteri di controllo qualità
22 agosto 2013
Primo Inserito (Stima)
27 agosto 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
8 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 luglio 2015
Ultimo verificato
1 luglio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12AST11894/A-12292
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .