Urinary CalculiNCT00397397
Comparative Treatment Study in Patients With Lower Ureteral Stones
An observational study of Urinary Calculi, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Calculi
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Mar 2007
- Phase
- Observational
- 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
- Clinical diagnosis of lower ureter (urinary calculi) up to 8mm
- Must be able to swallow tablets
Who cannot join
- Sensitivity to Alfuzosin and Rowatinex
- Pregnant and breastfeeding women
- Single kidney
- Obstructing stone
- Renal failure creatinine up to 1.8 mg/dl
- Patients using various alpha blockers
Show all 13Show fewer
- Liver failure
- Fever higher than 38 C
- UTI
- Syncope or hypotension
- Patients treated with PDE5
- Patients treated with inhibitor CYP3A4
- Patients refusing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone
We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?
Read the detailed description
The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.
- Conditions
- Urinary Calculi
- Keywords
- Urinary Calculi, Rowatinex, Alfuzosin, Drug Therapy
- Medical subject headings
- Urinary Calculi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies 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
- Observational
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Gabriel Faragi, Principal investigator, Urology Department, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397397
- Sponsor's protocol ID
- 15/2006CTIL
- Status last verified
- Nov 2006
- First submitted
- 8 Nov 2006
- Last updated
- 9 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone
- ClinicalTrials.gov ID
- NCT00397397
- Acronym / sponsor ID
- 15/2006CTIL
- Conditions
- Urinary Calculi
- Keywords
- Urinary Calculi, Rowatinex, Alfuzosin, Drug Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2007
- Study completion
- Mar 2007
- First posted
- 9 Nov 2006 (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 wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?
Detailed description
The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of lower ureter (urinary calculi) up to 8mm
- Must be able to swallow tablets
Key exclusion criteria (13 listed)
- Sensitivity to Alfuzosin and Rowatinex
- Pregnant and breastfeeding women
- Single kidney
- Obstructing stone
- Renal failure creatinine up to 1.8 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 9 Nov 2006.
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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.
Gabriel Faragi principal investigator
Urology Department, Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Calculi, run by Hillel Yaffe Medical Center at 1 site 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 2 inclusion and 13 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 9 Nov 2006. 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 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.
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.
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 Nov 2006.