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Longitudinal Study of Patients With Opioid-Induced Constipation

7 juli 2015 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Patients With Opioid Induced Constipation

Studietyp

Observationell

Inskrivning (Faktisk)

520

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
Rate of LIR among the OIC population Tidsram: 6 months	6 months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)