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Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery (oksineukir)

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. Identifier: NCT02573922
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: oxycodone-naloxone Drug: Oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Oxycodone-naloxone
Oxycodone-naloxone prolonged release tablet twice a day
Drug: oxycodone-naloxone
Active Comparator: Oxycodone
Oxycodone prolonged release tablet twice a day
Drug: Oxycodone

Primary Outcome Measures :
  1. opioid induced constipation [ Time Frame: from the surgery up to 21 days ]
    Opioid induced constipation was assessed with bowel function index

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02573922

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Kuopio University Hospital
Kuopio, Northern Savo, Finland, 70029
Sponsors and Collaborators
Kuopio University Hospital
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Principal Investigator: Merja Kokki, MD, PhD Kuopio University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merja Kokki, MD, PhD, Kuopio University Hospital Identifier: NCT02573922     History of Changes
Other Study ID Numbers: KUH24-02-2012
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Merja Kokki, Kuopio University Hospital:
spine surgery

Additional relevant MeSH terms:
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Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists