Kidney StonePhase 2/3NCT00428428
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
A Phase 2/3 study testing Isoproterenol in people with Kidney Stone and Unexplained Haematuria, run by Fredericia Hosptial at 1 site in Denmark.
Trial summary
The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Unexplained Haematuria, Benignant Tumour Mass in the Upper Urinary Tract
- What is being tested?
- Isoproterenol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to Nov 2007
- Phase
- Phase 2/3
- 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
- Indication for ureterorenoscopy
- Age> 18 years
- Normal blood pressure
Who cannot join
- Malignant disease in the upper urinary tract
- Heart disease
- Allergy to Isoproterenol
- Use of α-blocking or β-blocking medicine
- Use of Calcium-antagonists
- Use of NSAIDs the last 48 hours
Show all 10Show fewer
- Present stone or JJ-stent in the ureter
- Neurologic disease in the bladder
- Pregnancy
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dp. of Urology, Fredericia & Kolding Hospitals
Fredericia, Fredericia, 7000
About this study
The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.
- Being tested
- Isoproterenol
- Keywords
- kidney stone, ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoproterenolDrug
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline irrigation Receives: Drug: Isoproterenol |
| 2 | Active comparator | ISO irrigation Receives: Drug: Isoproterenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fredericia Hosptial
- Sponsor type
- University, hospital or other
- Investigators
- Palle JS Osther, PhD, MD, Study director, Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428428
- Sponsor's protocol ID
- HJ2
- Other IDs
- EudraCT nummer: 2006-005756-32
- Status last verified
- Nov 2007
- First submitted
- 29 Jan 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
- ClinicalTrials.gov ID
- NCT00428428
- Acronym / sponsor ID
- HJ2
- Keywords
- kidney stone, ureteroscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fredericia HosptialUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 30 Jan 2007 (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 the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: IsoproterenolSaline irrigation |
| 2 | Active comparator | Drug: IsoproterenolISO irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for ureterorenoscopy
- Age> 18 years
- Normal blood pressure
Key exclusion criteria (10 listed)
- Malignant disease in the upper urinary tract
- Heart disease
- Allergy to Isoproterenol
- Use of α-blocking or β-blocking medicine
- Use of Calcium-antagonists
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 |
|---|---|---|
| IsoproterenolISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation | Drug | 1, 2 |
Primary outcome
pelvic pressure
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 16 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.
Palle JS Osther, PhD, MD study director
Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Isoproterenol in people with Kidney Stone and Unexplained Haematuria, run by Fredericia Hosptial 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 10 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 16 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pelvic pressure. 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 Nov 2007.