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NCT02573922 Clinical Trial

Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

Constipation Clinical Trial

— oksineukir  

Official title:
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02573922
Other study ID # KUH24-02-2012
Secondary ID
Status Completed
Phase Phase 4
First received October 9, 2015
Last updated October 9, 2015
Start date May 2012
Est. completion date December 2014

Study information
Verified date October 2015
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• oxycodone-naloxone

• Oxycodone

Locations
Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (1)
Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary opioid induced constipation Opioid induced constipation was assessed with bowel function index from the surgery up to 21 days No
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