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Opioid-Induced ConstipationE-StOICNCT05149833

European Study of Opioid Induced Constipation

An observational study of Opioid-Induced Constipation, run by University of Dublin, Trinity College at 1 site in Ireland.

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

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-Induced Constipation
How many people
1,200 participants
Where
1 siteIreland
Study dates
16 Sep 2021to 31 Jul 2024
How long will I take part?
1 Day
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants may be inpatients, or outpatients at the study sites. Participants must meet all of the inclusion criteria for the study, and none of the exclusion criteria for the study. Participants must have a diagnosis of cancer and be on regular opioids for at least one week for cancer/ cancer treatment related pain.

Who may be able to join

  • Age 18 years or over
  • Diagnosis of cancer
  • Diagnosis of cancer pain or cancer treatment-related pain
  • Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid)

Who cannot join

  • Unable to provide consent
  • Unable to complete questionnaire

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Norah Fagan

    Dublin, D6W EV82

Other trials in Ireland

About this study

Official title: An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid Induced Constipation (OIC) in European Patients With Cancer Pain

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure.

OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

Read the detailed description

This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer.

Medical subject headings
Opioid-Induced Constipation

What is being measured

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

  1. Prevalence of opioid induced constipation (OIC)

    OIC diagnosed using Rome IV diagnostic criteria

    Measured: 5 minutes

Secondary outcomes (4)

  1. Impact of OIC on quality of life

    Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)

    Measured: 5 minutes

  2. Efficacy of treatment for OIC

    Bowel Function Index tool score Score 0-100 (better to worse)

    Measured: 3 minutes

  3. Adherence with treatment for OIC No scale - yes / no options

    Study questionnaire

    Measured: 5 minutes

  4. Use of non-prescribed treatments for OIC

    Study questionnaire No scale - yes / no options

    Measured: 5 minutes

Timeline

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

  1. First posted8 Dec 2021
  2. Study start16 Sep 2021
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

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
1,200 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149833
Sponsor's protocol ID
PM2021/65
Acronym
E-StOIC
Status last verified
Mar 2025
First submitted
5 Oct 2021
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fallon MT, Hanks GW. Morphine, constipation and performance status in advanced cancer patients. Palliat Med. 1999 Mar;13(2):159-60. doi: 10.1191/026921699677653615. No abstract available.

    PubMed 10474699

  • Goodman M, Low J, Wilkinson S. Constipation management in palliative care: a survey of practices in the United kingdom. J Pain Symptom Manage. 2005 Mar;29(3):238-44. doi: 10.1016/j.jpainsymman.2004.06.013.

    PubMed 15781174

  • van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Quality of life and non-pain symptoms in patients with cancer. J Pain Symptom Manage. 2009 Aug;38(2):216-33. doi: 10.1016/j.jpainsymman.2008.08.014. Epub 2009 Jun 28.

    PubMed 19564094

  • Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.

    PubMed 11331334

  • Davies A, Leach C, Butler C, Gregory A, Henshaw S, Minton O, Shorthose K, Batsari KM. Opioid-induced constipation in patients with cancer: a "real-world," multicentre, observational study of diagnostic criteria and clinical features. Pain. 2021 Jan;162(1):309-318. doi: 10.1097/j.pain.0000000000002024.

    PubMed 32701649

  • Walter S, Hallbook O, Gotthard R, Bergmark M, Sjodahl R. A population-based study on bowel habits in a Swedish community: prevalence of faecal incontinence and constipation. Scand J Gastroenterol. 2002 Aug;37(8):911-6. doi: 10.1080/003655202760230865.

    PubMed 12229965

  • Lee TH, Choi SC, Park MI, Park KS, Shin JE, Kim SE, Jung KW, Koo HS, Kim WJ, Cho YK, Kim YS, Lee JS. Constipation misperception is associated with gender, marital status, treatment utilization and constipation symptoms experienced. J Neurogastroenterol Motil. 2014 Jul 31;20(3):379-87. doi: 10.5056/jnm14011.

    PubMed 24935009

  • Davies A, Fagan N, Power J, Taylor A. 'Constipation': One word, many meanings amongst persons with cancer: An observational study. Palliat Med. 2025 May;39(5):553-562. doi: 10.1177/02692163251325711. Epub 2025 Mar 12.

    PubMed 40071858

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-Induced Constipation, run by University of Dublin, Trinity College at 1 site in Ireland.

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 4 inclusion and 2 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. 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?

Prevalence of opioid induced constipation (OIC) (time frame: 5 minutes). 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 NCT05149833, which also lists 8 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 3 Apr 2025.

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