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A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Mundipharma AB
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01109511
First received: April 15, 2010
Last updated: July 20, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Postoperative Pain
Opioid Induced Constipation
Drug: naloxone
Drug: oxycodone
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Constipation in subjects with postoperative pain

Study Start Date: April 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxycodone+naloxone Drug: naloxone Drug: oxycodone
Active Comparator: Control
Oxycodone alone without naloxone
Drug: oxycodone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109511

Locations
Norway
Dept of Anesthesiology, Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0407
Contact: Johan Raeder    +47 92249669    johan.rader@medisin.uio.no   
Principal Investigator: Johan Raeder         
Sponsors and Collaborators
Ullevaal University Hospital
Mundipharma AB
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01109511     History of Changes
Other Study ID Numbers: targiniqoxycodulleval
Study First Received: April 15, 2010
Last Updated: July 20, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Constipation
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Naloxone
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014