A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

• Sponsor: Ullevaal University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01109511
• Collaborator: Mundipharma AB (Industry)
• Enrollment: 85
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Opioid Induced Constipation	Drug: naloxone; Drug: oxycodone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Prevention
• Actual Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 30, 2011
• Actual Study Completion Date: Jul 30, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oxycodone+naloxone	Drug: naloxone; Drug: oxycodone
Active Comparator: Control Oxycodone alone without naloxone	Drug: oxycodone

Outcome Measures

Primary Outcome Measures

1. Constipation in subjects with postoperative pain [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Oslo		Norway	0407

Sponsors and Collaborators

• Ullevaal University Hospital
• Mundipharma AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johan C Ræder, Professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01109511
• Other Study ID Numbers: targiniqoxycodulleval
• First Posted: Apr 23, 2010
• Last Update Posted: Nov 5, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Constipation; Opioid-Induced Constipation; Oxycodone; Naloxone

Study Results

No Results Posted as of Nov 5, 2018