Distal UreterolithiasisPhase 4NCT00489112
The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study
A Phase 4 study testing Alfuzocine XL 10 mg once a day in people with Distal Ureterolithiasis, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Ureterolithiasis
- What is being tested?
- Alfuzocine XL 10 mg once a day
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Stone in the distal ureter until 1 cm of diameter
Who cannot join
- Evidence of urinary tract infection or sepsis
- Moderate or severe hydronephrosis
- Acute renal failure
- Ureteral stricture
- Stone with >1cm of diameter
- Previuos use of alpha blocker
- Pregnancy
- Previuos ureteral endoscopic or open surgery
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Haemek medical center,urology department
Afula, 18100
doron perez, M.D., +972-4-6495115, perez_do@clalit.org.il
- Recruiting
Haemek Medical Center
Afula, 18100
doron perez, MD, +972-4-6495115, perez_do@clalit.org.il
doron perez, MD
About this study
We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.
- Conditions
- Distal Ureterolithiasis
- Being tested
- Alfuzocine XL 10 mg once a day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzocine XL 10 mg once a dayDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal UreterolithiasisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- doron perez, M.D., Principal investigator, HaEmek MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489112
- Sponsor's protocol ID
- 0044-07-EMC
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00489112
- Acronym / sponsor ID
- 0044-07-EMC
- Conditions
- Distal Ureterolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- First posted
- 21 Jun 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.
We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stone in the distal ureter until 1 cm of diameter
Key exclusion criteria (8 listed)
- Evidence of urinary tract infection or sepsis
- Moderate or severe hydronephrosis
- Acute renal failure
- Ureteral stricture
- Stone with >1cm of diameter
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 |
|---|---|---|
| Alfuzocine XL 10 mg once a day | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
Related trials for Distal Ureterolithiasis
RecruitingPhase 2
Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.
Pediatric Urolithiasis, Distal Ureteral Stone
RecruitingPhase 2
L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
Distal Ureteral Stone, Urolithiasis
Recruiting
ESWL for Distal Ureteric Stone: Supine Versus Prone
Urinary Tract Stones, Urinary 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.
doron perez, M.D. principal investigator
HaEmek MC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfuzocine XL 10 mg once a day in people with Distal Ureterolithiasis, run by HaEmek Medical Center, Israel at 2 sites in Israel.
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 8 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 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Contact DORON PEREZ, M.D. (+972-4-6495115, perez_do@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Jun 2007.