ConstipationPhase 4oksisektioNCT02571881
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
A Phase 4 study testing Caesarean section, Oxycodone and oxycodone-naloxone in people with Constipation and Pain, Postoperative, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Constipation, Pain, Postoperative
- What is being tested?
- Caesarean section, Oxycodone and oxycodone-naloxone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to Dec 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • elective caesarean section in spinal anaesthesia
- normal full term single pregnancy
- age 18 years or more
- BMI 20 - 35 kg/m2
- written informed consent obtained
Who cannot join
- • not normal or full term pregnancy
- age less than 18 years
- allergy to study drugs
- substance misuse other contraindication to used study drugs no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.
- Conditions
- Constipation, Pain, Postoperative
- Being tested
- Caesarean section, Oxycodone, oxycodone-naloxone
- Keywords
- constipation, oxycodone, caesarean section
- Medical subject headings
- Constipation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caesarean sectionProcedure or surgery
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
OxycodoneDrug
oxycodone-naloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | Oxycodone 10 mg prolonged release tablet twice a day after caesarean section Receives: Procedure: Caesarean section; Drug: Oxycodone |
| Oxycodone-naloxone | Experimental | Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section Receives: Procedure: Caesarean section; Drug: oxycodone-naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with opioid induced bowel dysfunction assessed with bowel function index
Measured: time from the first drug intake up to three weeks postoperatively
Secondary outcomes (1)
Oxycodone concentrations in maternal plasma
Measured: time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Admescope Ltd
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
- Investigators
- Merja Kokki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571881
- Sponsor's protocol ID
- KUH01-07-2012
- Acronym
- oksisektio
- Status last verified
- Mar 2023
- First submitted
- 6 Oct 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT02571881
- Acronym / sponsor ID
- oksisektio / KUH01-07-2012
- Conditions
- Constipation, Pain, Postoperative
- Keywords
- constipation, oxycodone, caesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Admescope Ltd
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Oct 2015 (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.
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Procedure: Caesarean section, Drug: OxycodoneOxycodone 10 mg prolonged release tablet twice a day after caesarean section |
| Oxycodone-naloxone | Experimental | Procedure: Caesarean section, Drug: oxycodone-naloxoneOxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • elective caesarean section in spinal anaesthesia
Key exclusion criteria (4 listed)
- • not normal or full term pregnancy
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 |
|---|---|---|
| Caesarean sectionAfter caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication | Procedure or surgery | Oxycodone, Oxycodone-naloxone |
| Oxycodone | Drug | Oxycodone |
| oxycodone-naloxone | Drug | Oxycodone-naloxone |
Primary outcome
Number of patients with opioid induced bowel dysfunction assessed with bowel function index
Time frame: time from the first drug intake up to three weeks postoperatively
1 secondary outcome
Oxycodone concentrations in maternal plasma
Time frame: time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Merja Kokki, MD, PhD principal investigator
Kuopio 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 Caesarean section, Oxycodone and oxycodone-naloxone in people with Constipation and Pain, Postoperative, run by Kuopio University Hospital 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?
Results are not available in the source record.
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?
Number of patients with opioid induced bowel dysfunction assessed with bowel function index (time frame: time from the first drug intake up to three weeks postoperatively). 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 16 Mar 2023.