A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109511
Recruitment Status : Unknown
Verified April 2010 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : April 23, 2010
Last Update Posted : July 21, 2011
Mundipharma AB
Information provided by:
Oslo University Hospital

Brief Summary:


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 Type : Interventional  (Clinical Trial)
Study Start Date : April 2010
Actual Primary Completion Date : April 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Constipation in subjects with postoperative pain

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109511

Dept of Anesthesiology, Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0407
Contact: Johan Raeder    +47 92249669   
Principal Investigator: Johan Raeder         
Sponsors and Collaborators
Ullevaal University Hospital
Mundipharma AB Identifier: NCT01109511     History of Changes
Other Study ID Numbers: targiniqoxycodulleval
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: April 2010

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists