Renal CalculiPhase 3NCT01215708
Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
A Phase 3 study testing Tamsulosin in people with Renal Calculi, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Dec 2010
- 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
- radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix
Who cannot join
- inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of University of Sao Paulo
São Paulo, São Paulo, 05403900
About this study
Official title: Effect of Tamsulosin and Nifedipine on the Elimination of Fragments After Extracorporeal Shock Waves Lithotripsy in Patients With Kidney Stones - a Prospective, Double-blind and Randomized Study
The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.
Read the detailed description
Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.
- Conditions
- Renal Calculi
- Being tested
- Tamsulosin
- Keywords
- Kidney calculi, Lithotripsy, Calcium channel blockers, Adrenergic alpha-antagonists.
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called secotex
tamsulosin 0,4mg every night for 30 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | nifedipine retard 20mg daily Receives: Drug: Tamsulosin |
| tamsulosin | Active comparator | tamsulosin 0,4mg Receives: Drug: Tamsulosin |
| placebo | Placebo comparator | placebo capsule Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Measured: 30 days
Secondary outcomes (2)
To evaluate the effects of Tamsulosin and Nifedipine in the episodes of pain after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Measured: 30 days
To evaluate the effects of Tamsulosin and Nifedipine in the velocity of elimination of fragments after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Miguel Srougi, MD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215708
- Sponsor's protocol ID
- 278/06
- Status last verified
- Sep 2010
- First submitted
- 5 Oct 2010
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tamsulosin and Nifedipine on the Elimination of Fragments After Extracorporeal Shock Waves Lithotripsy in Patients With Kidney Stones - a Prospective, Double-blind and Randomized Study
- ClinicalTrials.gov ID
- NCT01215708
- Acronym / sponsor ID
- 278/06
- Conditions
- Renal Calculi
- Keywords
- Kidney calculi, Lithotripsy, Calcium channel blockers, Adrenergic alpha-antagonists.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 6 Oct 2010 (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 investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.
Detailed description
Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: Tamsulosinnifedipine retard 20mg daily |
| tamsulosin | Active comparator | Drug: Tamsulosintamsulosin 0,4mg |
| placebo | Placebo comparator | Drug: Tamsulosinplacebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix
Key exclusion criteria (1 listed)
- inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.
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 |
|---|---|---|
| TamsulosinAlso: secotextamsulosin 0,4mg every night for 30 consecutive days | Drug | Nifedipine, placebo, tamsulosin |
Primary outcome
To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Time frame: 30 days
2 secondary outcomes
To evaluate the effects of Tamsulosin and Nifedipine in the episodes of pain after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Time frame: 30 days
To evaluate the effects of Tamsulosin and Nifedipine in the velocity of elimination of fragments after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
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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.
Miguel Srougi, MD study chair
University of Sao Paulo
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 Tamsulosin in people with Renal Calculi, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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 6 Oct 2010. 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 Brazil. 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?
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.
What does the primary outcome measure?
To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL (time frame: 30 days). 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 6 Oct 2010.