Back to resultsA Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
Primary Purpose
Postoperative Pain, Opioid Induced Constipation
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
naloxone
oxycodone
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Females 18 -70 years
- Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
- Subjects willing and able to participate the study and have provided informed consent form -
Exclusion Criteria:
- Previous recent or regular opioid use (WHO step I pain treatment allowed)
- Any situation where opioids are contraindicated.
- Any history of moderate to severe hepatic impairment.
- Any history of severe respiratory depression with hypoxia and/or hypercapnia
- Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
- Subjects with evidence of non-opioid induced paralytic ileus
- Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
- Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
- Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
- Active alcohol or drug abuse and/or history of opioid abuse.
- Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
- Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
Sites / Locations
- Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
oxycodone+naloxone
Control
Arm Description
Oxycodone alone without naloxone
Outcomes
Primary Outcome Measures
Constipation in subjects with postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01109511
First Posted
April 15, 2010
Last Updated
November 1, 2018
Sponsor
Ullevaal University Hospital
Collaborators
Mundipharma AB
1. Study Identification
Unique Protocol Identification Number
NCT01109511
Brief Title
A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2010 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
July 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ullevaal University Hospital
Collaborators
Mundipharma AB
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Induced Constipation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxycodone+naloxone
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Oxycodone alone without naloxone
Intervention Type
Drug
Intervention Name(s)
naloxone
Intervention Type
Drug
Intervention Name(s)
oxycodone
Primary Outcome Measure Information:
Title
Constipation in subjects with postoperative pain
Time Frame
3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females 18 -70 years
Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
Subjects willing and able to participate the study and have provided informed consent form -
Exclusion Criteria:
Previous recent or regular opioid use (WHO step I pain treatment allowed)
Any situation where opioids are contraindicated.
Any history of moderate to severe hepatic impairment.
Any history of severe respiratory depression with hypoxia and/or hypercapnia
Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
Subjects with evidence of non-opioid induced paralytic ileus
Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
Active alcohol or drug abuse and/or history of opioid abuse.
Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
Facility Information:
Facility Name
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
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A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
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