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Patients With Opioid Induced ConstipationNCT01928953

Longitudinal Study of Patients With Opioid-Induced Constipation

An observational study of Patients With Opioid Induced Constipation, run by AstraZeneca at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
How many people
520 participants
Where
30 sitesin 2 countries
Study dates
Oct 2012to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States24 sites

  • Advanced Rx Clinical Research

    Artelia, California

  • Atco Medical Associates, P.C.

    Atco, New Jersey

  • Clinical Inquest Center LTD

    Beavercreek, Ohio

  • Alliance Clinical Research

    Birmingham, Alabama

  • Ohio Clinical Research Partners, LLC

    Canton, Ohio

  • Pain Research of Charleston

    Charleston, South Carolina

  • Gaffnew Health Services

    Charlotte, North Carolina

  • Chicago Anesthesia Pain Specialists

    Chicago, Illinois

  • Clinical Inquest Center, Ltd.

    Dayton, Ohio

  • TriWest Research Associates, LLC

    El Cajon, California

  • Southeast Clinical Research, LLC

    Jacksonville, Florida

  • Akkiance Research Centers

    Laguna Hills, California

  • Primecare Clinical Research

    Lajuna Hills, California

  • Samaritan Center for Medical Research

    Los Gatos, California

  • Horizon Research Group, Inc

    Mobile, Alabama

  • Family Medicine of SayeBrook

    Myrtle Beach, South Carolina

  • ActivMed Practices & Research

    Newington, New Hampshire

  • DiGiovanna Institute for medical Education and Research

    North Massapequa, New York

  • NPC Research

    Oklahoma City, Oklahoma

  • HOPE Research Institute

    Phoenix, Arizona

  • Highland Clinical Research

    Salt Lake City, Utah

  • Precision Research Institute, LLC

    San Diego, California

  • Physician Care Clinical Research, LLC

    Sarasota, Florida

  • Soth Miami Clinical Research

    South Miami, Florida

Other trials in United States

Canada6 sites

  • Aviva Clinical Trial Group Inc.

    Burlington, Ontario

  • University of Calgary

    Calgary, Alberta

  • SKDS Research Inc.

    Newmarket, Ontario

  • Taunton Health Centre

    Oshawa, Ontario

  • Paradise Medical Clinic

    Paradise, Newfoundland and Labrador

  • Pro-Recherche

    Saint Romuald, Quebec

Other trials in Canada

About this study

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.

Read more

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.
Keywords
opioid induced constipation in patients without cancer and with cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of LIR among the OIC population

    Measured: 6 months

Secondary outcomes (11)

  1. Rate of inadequate response to first and second-line laxative treatment for OIC (1x LIR and 2x LIR).

    Measured: 6 months

  2. Baseline demographic and clinical characteristics of patients with OIC (prior health status, comorbidities, GI symptoms, and concomitant medications).

    Measured: 12months retrospectively

  3. Drug utilization and self-management of OIC at baseline and changes from baseline over the 24-week follow-up period.

    Measured: 6 months

  4. Healthcare resource utilization profiles pre- and post-baseline

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 6 months

  8. Loss of productivity (WPAI-SHP score) at baseline and changes from baseline over the 24-week follow-up period.

    Measured: 6 months

  9. Persistence on opioid therapy at baseline and changes from baseline over the 24-week follow-up period

    Measured: 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.

    Measured: 6 months

  11. Physician-reported awareness of OIC and symptoms, and understanding of patient reported impact of OIC at baseline.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01928953
Sponsor's protocol ID
12AST11894/A-12292
Status last verified
Jul 2015
First submitted
22 Aug 2013
Last updated
8 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29420795

  • 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.

    PubMed 27003553

Questions about this trial

What is this clinical trial studying?

An observational study of Patients With Opioid Induced Constipation, run by AstraZeneca at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of LIR among the OIC population (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01928953, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.

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