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Study of Opioid-Induced Constipation 2 Project (StOIC-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404933
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Kyowa Hakko Kirin UK, Ltd.
Information provided by (Responsible Party):
Royal Surrey County Hospital NHS Foundation Trust

Brief Summary:

The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) efficacy of a treatment algorithm to manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs / other interventions to manage OIC.


Condition or disease Intervention/treatment
Opioid-induced Constipation Cancer Cancer Pain Other: Treatment algorithm for OIC

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation


Intervention Details:
  • Other: Treatment algorithm for OIC
    Treatment Algorithm for OIC


Primary Outcome Measures :
  1. Resolution of OIC [ Time Frame: 28 days ]
    BFI < 30


Secondary Outcome Measures :
  1. Improvement in BFI [ Time Frame: 28 days ]
    BFI improved by 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research
Criteria

Inclusion Criteria:

  • As per StOIC 1: age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week
  • Diagnosis of OIC as defined by the Rome IV criteria (Lacy et al, 2016)
  • Diagnosis of inadequately treated OIC as defined by BFI > 30

Exclusion Criteria:

  • As per StOIC 1: inability to give informed consent; inability yo complete questionnaire
  • Prognosis > 1 month

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): NCT04404933


Locations
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United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LQ
Brighton & Sussex University Hospitals
Brighton, East Sussex, United Kingdom, BN2 5BE
Leckhampton Court Hospice
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
Hospice of St. Francis
Berkhamstead, Hertfordshire, United Kingdom, HP43GW
Heart of Kent Hospice
Maidstone, Kent, United Kingdom, ME20 7PU
Wisdom Hospice
Rochester, Kent, United Kingdom, ME1 2NU
St. Raphael's Hospice
Cheam, London, United Kingdom, SM3 9DX
Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom
St Margaret's Hospice
Yeovil, Somerset, United Kingdom, BA20 2HU
St. Giles Hospice
Lichfield, Staffordshire, United Kingdom, WS14 9LH
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Birmingham St. Mary's Hospice
Birmingham, West Midlands, United Kingdom, B29 7DA
St. Catherine's Hospice
Crawley, West Sussex, United Kingdom, RH10 6BH
St. Gemma's Hospice
Leeds, Yorkshire, United Kingdom, LS17 6QD
Wheatfields Hospice
Leeds, Yorkshire, United Kingdom, LS6 2AE
St. Luke's Hospice
Sheffield, Yorkshire, United Kingdom, S11 9NE
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
Kyowa Hakko Kirin UK, Ltd.
Investigators
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Principal Investigator: Andrew Davies, MD Consultant Palliative Medicine
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04404933    
Other Study ID Numbers: StOIC-2 Project
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, there are no plans to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Surrey County Hospital NHS Foundation Trust:
Opioid-induced constipation
Additional relevant MeSH terms:
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Constipation
Cancer Pain
Opioid-Induced Constipation
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders