Postoperative PainPhase 4NCT01374763
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
A Phase 4 study testing Oxycodone and Prolonged-release oxycodone/naloxone in people with Postoperative Pain and Opioid Related Disorders, run by Kati Järvelä at 1 site in Finland.
Trial summary
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Opioid Related Disorders
- What is being tested?
- Oxycodone and Prolonged-release oxycodone/naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2011to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult cardiac surgery patient
Who cannot join
- Preoperative continuous use of laxatives
- Known anatomic or functional gastrointestinal disorder
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.
Read the detailed description
Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.
- Conditions
- Postoperative Pain, Opioid Related Disorders
- Being tested
- Oxycodone, Prolonged-release oxycodone/naloxone
- Keywords
- Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Prolonged-release oxycodone 10-30 mg twice daily
Prolonged-release oxycodone/naloxoneDrug
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | Drug: prolonged-release oxycodone Receives: Drug: Oxycodone |
| Oxycodone/naloxone | Active comparator | Prolonged-release oxycodone/naloxone Receives: Drug: Prolonged-release oxycodone/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of opioid-induced bowel dysfunction postoperatively
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (1)
Need of laxatives postoperatively
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kati Järvelä
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kati Järvelä, Tampere University Hospital
- Investigators
- Kati Järvelä, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374763
- Sponsor's protocol ID
- R10133M
- Other IDs
- 2010-023025-37
- Status last verified
- Feb 2012
- First submitted
- 26 May 2011
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01374763
- Acronym / sponsor ID
- R10133M
- Conditions
- Postoperative Pain, Opioid Related Disorders
- Keywords
- Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kati JärveläUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jun 2011 (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.
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.
Detailed description
Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Drug: OxycodoneDrug: prolonged-release oxycodone |
| Oxycodone/naloxone | Active comparator | Drug: Prolonged-release oxycodone/naloxoneProlonged-release oxycodone/naloxone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult cardiac surgery patient
Key exclusion criteria (2 listed)
- Preoperative continuous use of laxatives
- Known anatomic or functional gastrointestinal disorder
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 |
|---|---|---|
| OxycodoneProlonged-release oxycodone 10-30 mg twice daily | Drug | Oxycodone |
| Prolonged-release oxycodone/naloxoneProlonged-release oxycodone/naloxone 10-30 mg twice daily | Drug | Oxycodone/naloxone |
Primary outcome
Duration of opioid-induced bowel dysfunction postoperatively
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
1 secondary outcome
Need of laxatives postoperatively
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 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 20 Feb 2012.
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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.
Kati Järvelä, MD, PhD principal investigator
Tampere 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 and Prolonged-release oxycodone/naloxone in people with Postoperative Pain and Opioid Related Disorders, run by Kati Järvelä at 1 site in Finland.
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 1 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 20 Feb 2012. 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 Finland. 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?
Duration of opioid-induced bowel dysfunction postoperatively (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 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 20 Feb 2012; AzTrials last refreshed its copy on 6 Nov 2026.