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Trial record 83 of 146 for:    NIFEDIPINE

Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215708
Recruitment Status : Unknown
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2010
Last Update Posted : October 6, 2010
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE October 5, 2010
First Posted Date  ICMJE October 6, 2010
Last Update Posted Date October 6, 2010
Study Start Date  ICMJE August 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Renal Calculi
Intervention  ICMJE Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
Study Arms  ICMJE
  • Active Comparator: Nifedipine
    nifedipine retard 20mg daily
    Intervention: Drug: Tamsulosin
  • Active Comparator: tamsulosin
    tamsulosin 0,4mg
    Intervention: Drug: Tamsulosin
  • Placebo Comparator: placebo
    placebo capsule
    Intervention: Drug: Tamsulosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 5, 2010)
136
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01215708
Other Study ID Numbers  ICMJE 278/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabio Carvalho Vicentini, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators  ICMJE
Study Chair: Miguel Srougi, MD University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP