Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

NCT ID: NCT02573922

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxycodone-naloxone

Oxycodone-naloxone prolonged release tablet twice a day

Group Type EXPERIMENTAL

oxycodone-naloxone

Intervention Type DRUG

Oxycodone

Oxycodone prolonged release tablet twice a day

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Interventions

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oxycodone-naloxone

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merja Kokki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 30073471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27921252 (View on PubMed)

Other Identifiers

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KUH24-02-2012

Identifier Type: -

Identifier Source: org_study_id

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