Kidney CalculiPhase 3NCT00177086
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
A Phase 3 study testing Alfuzosin Hydrochloride in people with Kidney Calculi and Ureteral Calculi, run by University of Minnesota at 1 site in United States.
Trial summary
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Ureteral Calculi, Colic
- What is being tested?
- Alfuzosin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2008
- 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
- <8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram
Who cannot join
- Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
- Pregnant/Nursing females
- Solitary kidney
- Renal insufficiency (Creatinine>1.8)
- Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
- Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C)
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- Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased
- Other alpha-blockers
- Phosphodiesterase type 5 inhibitors for erectile dysfunction
- Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.
- Conditions
- Kidney Calculi, Ureteral Calculi, Colic
- Being tested
- Alfuzosin Hydrochloride
- Medical subject headings
- Kidney Calculi, Ureteral Calculi, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin HydrochlorideOther
Also called Sugar pill
One tablet every day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alfuzosin | Experimental | Not described Receives: Other: Alfuzosin Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Other: Alfuzosin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous stone passage for distal ureteral calculi
Measured: increased
Secondary outcomes (3)
Decrease the pain and narcotic use associated with stone passage
Measured: decrease
Decrease the time to spontaneous passage
Measured: decrease
Shift the size distribution of stones passed towards larger sizes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Manoj, Monga, M.D.
- Responsible party
- Sponsor
- Investigators
- Manoj Monga, MD, Principal investigator, University of Minnesota and VAMC Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177086
- Sponsor's protocol ID
- 0412M65851
- Other IDs
- L9839, 3579B
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
- ClinicalTrials.gov ID
- NCT00177086
- Acronym / sponsor ID
- 0412M65851
- Conditions
- Kidney Calculi, Ureteral Calculi, Colic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Manoj, Monga, M.D.
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Sep 2005 (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.
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfuzosin | Experimental | Other: Alfuzosin Hydrochloride |
| Placebo | Placebo comparator | Other: Alfuzosin Hydrochloride |
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
- <8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram
Key exclusion criteria (10 listed)
- Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
- Pregnant/Nursing females
- Solitary kidney
- Renal insufficiency (Creatinine>1.8)
- Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
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 |
|---|---|---|
| Alfuzosin HydrochlorideAlso: Sugar pillOne tablet every day for 4 weeks | Other | Alfuzosin, Placebo |
Primary outcome
Spontaneous stone passage for distal ureteral calculi
Time frame: increased
3 secondary outcomes
Decrease the pain and narcotic use associated with stone passage
Time frame: decrease
Decrease the time to spontaneous passage
Time frame: decrease
Shift the size distribution of stones passed towards larger sizes
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 18 Mar 2013.
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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.
Manoj Monga, MD principal investigator
University of Minnesota and VAMC Minneapolis
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 Alfuzosin Hydrochloride in people with Kidney Calculi and Ureteral Calculi, run by University of Minnesota at 1 site in United States.
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 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 18 Mar 2013. 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 United States. 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 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?
Spontaneous stone passage for distal ureteral calculi (time frame: increased). 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 18 Mar 2013.