A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

NCT01109511 | Completed Phase 4

• 1 other identifier: targiniqoxycodulleval
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Opioid Induced Constipation

Outcome Measures

Primary Outcomes (1)

• Constipation in subjects with postoperative pain

  3 days

Study Arms (2)

oxycodone+naloxone

ACTIVE COMPARATOR

Drug: naloxone; Drug: oxycodone

Control

ACTIVE COMPARATOR

Oxycodone alone without naloxone

Drug: oxycodone

Interventions

naloxone DRUG

oxycodone+naloxone

oxycodone DRUG

Control; oxycodone+naloxone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Mundipharma AB: collaborator

Study Sites (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative; Opioid-Induced Constipation

Interventions

Naloxone; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Constipation; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Morphine Derivatives

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 23, 2010
• Study Start: March 1, 2010
• Primary Completion: June 30, 2011
• Study Completion: July 30, 2011
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

NO (1)