Postoperative PainPhase 4NCT01109511
A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
A Phase 4 study testing naloxone and oxycodone in people with Postoperative Pain and Opioid Induced Constipation, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Opioid Induced Constipation
- What is being tested?
- naloxone and oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2010to 30 Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 -70 years
- Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
- Subjects willing and able to participate the study and have provided informed consent form -
Who cannot join
- Previous recent or regular opioid use (WHO step I pain treatment allowed)
- Any situation where opioids are contraindicated.
- Any history of moderate to severe hepatic impairment.
- Any history of severe respiratory depression with hypoxia and/or hypercapnia
- Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
- Subjects with evidence of non-opioid induced paralytic ileus
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- Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
- 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.
- Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
- Active alcohol or drug abuse and/or history of opioid abuse.
- 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.
- Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
About this study
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
- Being tested
- naloxone, oxycodone
- Medical subject headings
- Pain, Postoperative, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxoneDrug
oxycodoneDrug
| Study group | Role | What they receive |
|---|---|---|
| oxycodone+naloxone | Active comparator | Not described Receives: Drug: naloxone; Drug: oxycodone |
| Control | Active comparator | Oxycodone alone without naloxone Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation in subjects with postoperative pain
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start1 Mar 2010
- Primary completion30 Jun 2011
- Study completion30 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma AB
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109511
- Sponsor's protocol ID
- targiniqoxycodulleval
- Status last verified
- Nov 2018
- First submitted
- 15 Apr 2010
- Last updated
- 5 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01109511
- Acronym / sponsor ID
- targiniqoxycodulleval
- Conditions
- Postoperative Pain, Opioid Induced Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Mundipharma AB
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jul 2011 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxycodone+naloxone | Active comparator | Drug: naloxone, Drug: oxycodone |
| Control | Active comparator | Drug: oxycodoneOxycodone alone without naloxone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females 18 -70 years
- Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
- Subjects willing and able to participate the study and have provided informed consent form -
Key exclusion criteria (12 listed)
- Previous recent or regular opioid use (WHO step I pain treatment allowed)
- Any situation where opioids are contraindicated.
- Any history of moderate to severe hepatic impairment.
- Any history of severe respiratory depression with hypoxia and/or hypercapnia
- Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naloxone | Drug | oxycodone+naloxone |
| oxycodone | Drug | Control, oxycodone+naloxone |
Primary outcome
Constipation in subjects with postoperative pain
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naloxone and oxycodone in people with Postoperative Pain and Opioid Induced Constipation, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation in subjects with postoperative pain (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.