- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573922
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery (oksineukir)
October 9, 2015 updated by: Merja Kokki, Kuopio University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northern Savo
-
Kuopio, Northern Savo, Finland, 70029
- Kuopio University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 17 - 35 kg/m2
- elective spine surgery
- informed consent obtained
Exclusion Criteria:
- allergy to the used drugs
- other contraindication to oxycodone medication
- no informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxycodone-naloxone
Oxycodone-naloxone prolonged release tablet twice a day
|
|
Active Comparator: Oxycodone
Oxycodone prolonged release tablet twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
opioid induced constipation
Time Frame: from the surgery up to 21 days
|
Opioid induced constipation was assessed with bowel function index
|
from the surgery up to 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Kokki 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
October 9, 2015
First Submitted That Met QC Criteria
October 9, 2015
First Posted (Estimate)
October 12, 2015
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
October 9, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Narcotic-Related Disorders
- Constipation
- Intestinal Diseases
- Opioid-Induced Constipation
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Naloxone
- Oxycodone
Other Study ID Numbers
- KUH24-02-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation
-
usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional Constipation (FC) | Chronic Idiopathic Constipation (CIC)United States, United Kingdom, Bulgaria, Netherlands
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
SK Life Science, Inc.CompletedChronic Constipation | Functional ConstipationUnited States
-
Cairo UniversityUnknownChronic Idiopathic Constipation | Functional ConstipationEgypt
-
ProgenaBiomeRecruitingConstipation | Constipation - Functional | Constipation Chronic Idiopathic | Constipation (Excl Faecal Impaction)United States
-
Pamukkale UniversityRecruiting
-
Shanghai University of Traditional Chinese MedicineLonghua Hospital; Shanghai Municipal Hospital of Traditional Chinese MedicineRecruiting
-
Universidade Nova de LisboaCINTESIS - Center for Health Technology and Services ResearchRecruiting
Clinical Trials on Oxycodone
-
Poznan University of Medical SciencesCompleted
-
Mount Carmel Health SystemWithdrawnPost-operative Pain ControlUnited States
-
Sharon WalshNational Institute on Drug Abuse (NIDA); Merck Sharp & Dohme LLCCompleted
-
Grünenthal GmbHCompleted
-
Yong-Hee ParkChung-Ang UniversityCompletedBlood Pressure | Intubation ComplicationKorea, Republic of
-
Seoul National University HospitalWithdrawnPainKorea, Republic of
-
Egalet LtdCompletedModerate-to-severe Chronic Low Back PainUnited States
-
Kuopio University HospitalAdmescope LtdActive, not recruiting
-
Seoul National University HospitalCompleted