Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
oksineukir
1 other identifier
interventional
180
1 country
1
Brief Summary
In the present study, the primary aim was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced opioid induced constipation in patients with or without chronic opioid treatment undergoing spine surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedOctober 12, 2015
October 1, 2015
2.6 years
October 9, 2015
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
opioid induced constipation
Opioid induced constipation was assessed with bowel function index
from the surgery up to 21 days
Study Arms (2)
Oxycodone-naloxone
EXPERIMENTALOxycodone-naloxone prolonged release tablet twice a day
Oxycodone
ACTIVE COMPARATOROxycodone prolonged release tablet twice a day
Interventions
Eligibility Criteria
You may qualify if:
- BMI 17 - 35 kg/m2
- elective spine surgery
- informed consent obtained
You may not qualify if:
- allergy to the used drugs
- other contraindication to oxycodone medication
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
Related Publications (2)
Kuronen M, Kokki H, Nyyssonen T, Savolainen S, Kokki M. Life satisfaction and pain interference in spine surgery patients before and after surgery: comparison between on-opioid and opioid-naive patients. Qual Life Res. 2018 Nov;27(11):3013-3020. doi: 10.1007/s11136-018-1961-x. Epub 2018 Aug 2.
PMID: 30073471DERIVEDKokki M, Kuronen M, Naaranlahti T, Nyyssonen T, Pikkarainen I, Savolainen S, Kokki H. Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment. Adv Ther. 2017 Jan;34(1):236-251. doi: 10.1007/s12325-016-0456-9. Epub 2016 Dec 5.
PMID: 27921252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merja Kokki, MD, PhD
Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 12, 2015
Study Start
May 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 12, 2015
Record last verified: 2015-10