Pain, PostoperativePhase 4NCT00964808
Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
A Phase 4 study testing Buprenorphine and Oxycodone in people with Pain, Postoperative, run by Vejle Hospital at 1 site in Denmark.
Trial summary
Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine. This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Buprenorphine and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Aug 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age 18 years or more
- X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.
- Subjects must have 7 or more points in the Hindsøes test.
Who cannot join
- Subjects where spinal anaesthesia cannot be applied.
- Subject in Plavix® treatment seven days before admission to the hospital.
- Subjects with extracapsular hip fracture due to bone metastasis.
- Subjects with a BMI over 30.
- Subjects under 45 kg.
- Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior admission to the hospital.
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- Substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior.
- Untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject.
- Dermatological disorder at any relevant patch application site.
- Any contraindications listed in the Summary of Product Characteristics for Norspan®, OxyNorm® and OxyContin®.
- Patient does not tolerate oxynorm.
- User of wheelchair.
- Daily use of morphine before hospitalization.
- More than one fracture. Patients with myasthenia gravis. Patients with severe respiratory function. Patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating
Trial locations and contacts
1 site in 1 country.
About this study
Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine.
This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?
- Conditions
- Pain, Postoperative
- Being tested
- Buprenorphine, Oxycodone
- Keywords
- Hip fractures, Treatment Outcome, Painkiller
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called Norspan
Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
OxycodoneDrug
Also called Oxycontin
Start: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg * 2 pr. day until time to discharge from the Hospital or latest at day 12.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Double dummy; Group A: Active Buprenorphine and placebo oxycodone Receives: Drug: Buprenorphine |
| Oxycodone | Experimental | Double Dummy:
Group B: Placebo Buprenorphine and Active Oxycodone Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobilization measured daily using Cumulated Ambulation Score.
Measured: 12 days
Secondary outcomes (4)
Pain intensity measured daily on a verbal rating scale
Measured: 12 days
Adverse effects
Measured: 12 days + 14 days
Opioid consumption.
Measured: 12 days
Length of stay in Hospital
Measured: Untill discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norpharma A/S
- Responsible party
- Sponsor
- Investigators
- Per Kjaersgaard-Andersen, MD, Study director, Orthopaedic Department, Vejle Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964808
- Sponsor's protocol ID
- EudraCT2009-010539-41
- Status last verified
- Dec 2014
- First submitted
- 24 Aug 2009
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
- ClinicalTrials.gov ID
- NCT00964808
- Acronym / sponsor ID
- EudraCT2009-010539-41
- Conditions
- Pain, Postoperative
- Keywords
- Hip fractures, Treatment Outcome, Painkiller
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Norpharma A/S
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Aug 2009 (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.
Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine.
This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphineDouble dummy; Group A: Active Buprenorphine and placebo oxycodone |
| Oxycodone | Experimental | Drug: OxycodoneDouble Dummy: Group B: Placebo Buprenorphine and Active Oxycodone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females age 18 years or more
- X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.
- Subjects must have 7 or more points in the Hindsøes test.
Key exclusion criteria (14 listed)
- Subjects where spinal anaesthesia cannot be applied.
- Subject in Plavix® treatment seven days before admission to the hospital.
- Subjects with extracapsular hip fracture due to bone metastasis.
- Subjects with a BMI over 30.
- Subjects under 45 kg.
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 |
|---|---|---|
| BuprenorphineAlso: NorspanStart: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days. | Drug | Buprenorphine |
| OxycodoneAlso: OxycontinStart: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg * 2 pr. day until time to discharge from the Hospital or latest at day 12. | Drug | Oxycodone |
Primary outcome
Mobilization measured daily using Cumulated Ambulation Score.
Time frame: 12 days
4 secondary outcomes
Pain intensity measured daily on a verbal rating scale
Time frame: 12 days
Adverse effects
Time frame: 12 days + 14 days
Opioid consumption.
Time frame: 12 days
Length of stay in Hospital
Time frame: Untill discharge
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 8 Dec 2014.
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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.
Per Kjaersgaard-Andersen, MD study director
Orthopaedic Department, Vejle Hospital, Denmark
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 Buprenorphine and Oxycodone in people with Pain, Postoperative, run by Vejle Hospital 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 3 inclusion and 14 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 8 Dec 2014. 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?
Mobilization measured daily using Cumulated Ambulation Score. (time frame: 12 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 8 Dec 2014.