Status:
COMPLETED
Study of Opioid-Induced Constipation 2 Project
Lead Sponsor:
Royal Surrey County Hospital NHS Foundation Trust
Collaborating Sponsors:
Kyowa Hakko Kirin UK, Ltd.
Conditions:
Opioid-induced Constipation
Cancer
Eligibility:
All Genders
18+ years
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 OI...
Detailed Description
StOIC-2 is an observational study of routine clinical practice, and will involve four assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2 study will be identif...
Eligibility Criteria
Inclusion
- 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
- As per StOIC 1: inability to give informed consent; inability yo complete questionnaire
- Prognosis \> 1 month
Key Trial Info
Start Date :
August 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04404933
Start Date
August 21 2017
End Date
August 30 2019
Last Update
May 28 2020
Active Locations (16)
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1
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LQ
2
Brighton & Sussex University Hospitals
Brighton, East Sussex, United Kingdom, BN2 5BE
3
Leckhampton Court Hospice
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
4
Hospice of St. Francis
Berkhamstead, Hertfordshire, United Kingdom, HP43GW