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A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

NCT01109511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-11-05

No results posted yet for this study

Summary

Objectives:

Primary objective:

* To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is superior to the treatment with OxyPR with regards to constipation in subjects with postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1 week postoperatively.

The secondary objectives:

* Analgesic effect (including registration during the first 24 hrs)
* To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72 hrs)
* Frequency of nausea and vomiting
* Frequency of other adverse events
* Appetite
* Mobilization

The exploratory objectives:

* Overall patient satisfaction at 24, 72 hrs and 1 week

Conditions

  • Postoperative Pain
  • Opioid Induced Constipation

Interventions

DRUG

naloxone

DRUG

oxycodone

Sponsors & Collaborators

  • Mundipharma AB

    collaborator INDUSTRY

  • Ullevaal University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2011-06-30
Completion
2011-07-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109511 on ClinicalTrials.gov