A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

NCT ID: NCT01109511

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2011-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Study Groups

oxycodone+naloxone

Group Type: ACTIVE_COMPARATOR

naloxone

Intervention Type: DRUG

oxycodone

Intervention Type: DRUG

Control

Oxycodone alone without naloxone

Group Type: ACTIVE_COMPARATOR

oxycodone

Intervention Type: DRUG

Interventions

naloxone

Intervention Type: DRUG

oxycodone

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma AB

INDUSTRY

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Johan C Ræder

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Countries

Norway

Other Identifiers

targiniqoxycodulleval

Identifier Type: -

Identifier Source: org_study_id