Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Sao Paulo General Hospital
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01215708
First received: October 5, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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Purpose
The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Calculi |
Drug: Tamsulosin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 136 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nifedipine
nifedipine retard 20mg daily
|
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
|
|
Active Comparator: tamsulosin
tamsulosin 0,4mg
|
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
|
|
Placebo Comparator: placebo
placebo capsule
|
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix
Exclusion Criteria:
- inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215708
Locations
| Brazil | |
| Clinics Hospital of University of Sao Paulo | |
| Sao Paulo, Brazil, 05403900 | |
Sponsors and Collaborators
University of Sao Paulo General Hospital
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
| Study Chair: | Miguel Srougi, MD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Fabio Carvalho Vicentini, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01215708 History of Changes |
| Other Study ID Numbers: | 278/06 |
| Study First Received: | October 5, 2010 |
| Last Updated: | October 5, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
Kidney calculi Lithotripsy Calcium channel blockers Adrenergic alpha-antagonists. |
Additional relevant MeSH terms:
|
Kidney Calculi Calculi Pathological Conditions, Anatomical Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Adrenergic alpha-Antagonists Tamsulosin Calcium Channel Blockers Nifedipine Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Membrane Transport Modulators Cardiovascular Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013