A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Induced Constipation
• Intervention / Treatment: Drug: naloxone; Drug: oxycodone

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females 18 -70 years
2. Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
3. Subjects willing and able to participate the study and have provided informed consent form -

Exclusion Criteria:

1. Previous recent or regular opioid use (WHO step I pain treatment allowed)
2. Any situation where opioids are contraindicated.
3. Any history of moderate to severe hepatic impairment.
4. Any history of severe respiratory depression with hypoxia and/or hypercapnia
5. Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
6. Subjects with evidence of non-opioid induced paralytic ileus
7. Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
8. 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.
9. Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
10. Active alcohol or drug abuse and/or history of opioid abuse.
11. 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.
12. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: oxycodone+naloxone	Drug: naloxone; Drug: oxycodone
ACTIVE_COMPARATOR: Control; Oxycodone alone without naloxone	Drug: oxycodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Constipation in subjects with postoperative pain	3 days

Collaborators and Investigators

• Sponsor: Ullevaal University Hospital
• Collaborators: Mundipharma AB

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2010
• Primary Completion (ACTUAL): June 30, 2011
• Study Completion (ACTUAL): July 30, 2011

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Opioid-Induced Constipation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: targiniqoxycodulleval