PainPhase 4NCT00369811
Oxycodone vs Fentanyl for Pain Treatment After Laparoscopic Cholecystectomy
A Phase 4 study testing Oxycodone, fentanyl in people with Pain, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Oxycodone, fentanyl
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Sep 2007
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned outpatient laparoscopic cholecystectomy
- >18 years
Who cannot join
- Intolerance to study drugs
- Treatment with MAO inhibitors
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Comparative Study of Oxycodone and Fentanyl Given Intravenously in the Treatment of Early Postoperative Pain After Laparoscopic Cholecystectomy
To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.
- Conditions
- Pain
- Being tested
- Oxycodone, fentanyl
- Keywords
- Cholecystectomy, postoperative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone, fentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Lone Nikolajsen, MD, PhD, Principal investigator, Danish Pain Research Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369811
- Sponsor's protocol ID
- OXFEN2006
- Status last verified
- Nov 2007
- First submitted
- 28 Aug 2006
- Last updated
- 19 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Oxycodone and Fentanyl Given Intravenously in the Treatment of Early Postoperative Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00369811
- Acronym / sponsor ID
- OXFEN2006
- Conditions
- Pain
- Keywords
- Cholecystectomy, postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Aug 2006 (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.
To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned outpatient laparoscopic cholecystectomy
- >18 years
Key exclusion criteria (2 listed)
- Intolerance to study drugs
- Treatment with MAO inhibitors
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 |
|---|---|---|
| Oxycodone, fentanyl | Drug | – |
Primary outcome
Pain intensity
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 19 Nov 2007.
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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.
Lone Nikolajsen, MD, PhD principal investigator
Danish Pain Research Center, Aarhus University Hospital
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 Oxycodone, fentanyl in people with Pain, run by Danish Pain Research Center at 1 site in Denmark.
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 2 inclusion and 2 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 19 Nov 2007. 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 Denmark. 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?
Pain intensity. 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 19 Nov 2007.