Kidney StonesPhase 3NCT00784472
Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
A Phase 3 study testing oxycodone and morphine in people with Kidney Stones, run by Katja venborg Pedersen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- oxycodone and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to Jun 2012
- Phase
- Phase 3
- 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
- Age > 18
- Indication for PCNL
Who cannot join
- Malignant disease in the upper urinary tract
- Allergy to morphine or oxycodone
- Use of opioids the last 48 hours before PCNL
- Pregnancy
- Nursing mothers
- Present JJ-stent in the ureter
- Previous urinary stone disease on the opposite site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
The purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.
Read the detailed description
Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.
Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.
- Conditions
- Kidney Stones
- Keywords
- PCNL, oxycodone, morphine, visceral pain
- Medical subject headings
- Kidney Calculi, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodoneDrug
Also called oxynorm N02A A05
intravenous according to patients weight, pn.
morphineDrug
Also called morphine SAD N02 AA 01
intravenous administration according to patients weight, pn.
| Study group | Role | What they receive |
|---|---|---|
| oxycodone | Active comparator | Not described Receives: Drug: oxycodone |
| morphine | Active comparator | Not described Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of analgetics used
Measured: four hours postoperatively
Secondary outcomes (1)
Side effects
Measured: four hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katja venborg Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Katja venborg Pedersen, Fredericia Hosptial
- Investigators
- Palle Osther, Professor, Study chair, Hospital Little Belt, Fredericiakatja Venborg Pedersen, MD, Principal investigator, Hospital Little Belt, Fredericia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784472
- Sponsor's protocol ID
- VEN 1
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2008
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT00784472
- Acronym / sponsor ID
- VEN 1
- Conditions
- Kidney Stones
- Keywords
- PCNL, oxycodone, morphine, visceral pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Katja venborg PedersenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Nov 2008 (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 purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.
Detailed description
Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.
Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.
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 |
|---|---|---|
| oxycodone | Active comparator | Drug: oxycodone |
| morphine | Active comparator | Drug: morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Indication for PCNL
Key exclusion criteria (7 listed)
- Malignant disease in the upper urinary tract
- Allergy to morphine or oxycodone
- Use of opioids the last 48 hours before PCNL
- Pregnancy
- Nursing mothers
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 |
|---|---|---|
| oxycodoneAlso: oxynorm N02A A05intravenous according to patients weight, pn. | Drug | oxycodone |
| morphineAlso: morphine SAD N02 AA 01intravenous administration according to patients weight, pn. | Drug | morphine |
Primary outcome
Amount of analgetics used
Time frame: four hours postoperatively
1 secondary outcome
Side effects
Time frame: four hours postoperatively
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 9 Jul 2012.
Related trials for Kidney Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
Palle Osther, Professor study chair
Hospital Little Belt, Fredericia
katja Venborg Pedersen, MD principal investigator
Hospital Little Belt, Fredericia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxycodone and morphine in people with Kidney Stones, run by Katja venborg Pedersen 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 7 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 9 Jul 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Amount of analgetics used (time frame: four hours 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 9 Jul 2012.