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Longitudinal Study of Patients With Opioid-Induced Constipation

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ClinicalTrials.gov Identifier: NCT01928953
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

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.

Condition or disease
Patients With Opioid Induced Constipation

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Study Type : Observational
Actual Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Patients With Opioid-Induced Constipation
Study Start Date : October 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation




Primary Outcome Measures :
  1. Rate of LIR among the OIC population [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR). [ Time Frame: 6 months ]
  2. Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications). [ Time Frame: 12months retrospectively ]
  3. Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period. [ Time Frame: 6 months ]
  4. Healthcare resource utilization profiles pre- and post-baseline [ Time Frame: 6 months ]
  5. 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. [ Time Frame: 6 months ]
  6. Baseline constipation-associated GI symptoms and changes from baseline over the 24-week follow-up period (PAC-SYM and additional symptom questions). [ Time Frame: 6 months ]
  7. Baseline health-related quality of life (PAC-QOL and EQ-5D) and changes from baseline over the 24-week follow-up period (PAC-QOL). [ Time Frame: 6 months ]
  8. Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period. [ Time Frame: 6 months ]
  9. Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period [ Time Frame: 6 months ]
  10. Treatment satisfaction with laxative use at baseline and changes from baseline over the 24-week follow-up period, for all patients taking laxatives. [ Time Frame: 6 months ]
  11. Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928953


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Mark Sostek, M.D. AstraZeneca
Study Director: Cathy Datto, M.D., M.S. AstraZeneca
Principal Investigator: Robert J LoCasale, Phd, MS AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01928953     History of Changes
Other Study ID Numbers: 12AST11894/A-12292
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by AstraZeneca:
opioid induced constipation in patients without cancer and with cancer

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents