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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.
 
ClinicalTrials.gov Identifier: NCT01109511
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Mundipharma AB
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Actual Study Start Date : March 1, 2010
Actual Primary Completion Date : June 30, 2011
Actual Study Completion Date : July 30, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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 [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

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 ClinicalTrials.gov identifier (NCT number): NCT01109511


Locations
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Norway
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Mundipharma AB
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Responsible Party: Johan C Ræder, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01109511    
Other Study ID Numbers: targiniqoxycodulleval
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Constipation
Opioid-Induced Constipation
Signs and Symptoms, Digestive
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists