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Medical Expulsive Therapy of Single Distal Ureteral Stones

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00831701
First received: November 19, 2008
Last updated: May 19, 2010
Last verified: May 2010
Results First Received: January 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ureteral Calculi
Interventions: Drug: Tamsulosin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent

Reporting Groups
  Description
Tamsulosin Treatment Patients received one pill of Tamsulosin 400 micrograms once daily
Placebo Treatment Patients received Placebo pill once daily

Participant Flow:   Overall Study
    Tamsulosin Treatment     Placebo Treatment  
STARTED     50     50  
COMPLETED     45     45  
NOT COMPLETED     5     5  
Withdrawal by Subject                 2                 0  
Stone expulsion before first medication                 2                 2  
Lost to Follow-up                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tamsulosin Treatment Patients received one pill of Tamsulosin 400 micrograms once daily
Placebo Treatment Patients received Placebo pill once daily
Total Total of all reporting groups

Baseline Measures
    Tamsulosin Treatment     Placebo Treatment     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     48     45     93  
>=65 years     2     5     7  
Age  
[units: years]
Mean ± Standard Deviation
  38.2  ± 12.7     43.4  ± 13.9     40.8  ± 13.5  
Gender  
[units: participants]
     
Female     8     11     19  
Male     42     39     81  
Region of Enrollment  
[units: participants]
     
Switzerland     50     50     100  



  Outcome Measures
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1.  Primary:   Number of Participants With Stone Expulsion   [ Time Frame: 21 days ]

2.  Secondary:   Time to Stone Passage   [ Time Frame: 21 days ]

3.  Secondary:   Required Analgesics   [ Time Frame: Until stone expulsion or up to 21 days ]

4.  Secondary:   Maximum Daily Pain Score   [ Time Frame: Until stone expulsion or up to 21 days ]

5.  Secondary:   Number of Participants Requiring Active Treatment   [ Time Frame: 21 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not all patients were able to record the exact time of stone passage. Thus, the secondary end point of time to stone passage is based on Kaplan-Meier estimation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Räto T. Strebel
Organization: Department of Urology, University Hospital Zürich, Switzerland
phone: 0041-44-2551111
e-mail: raeto.strebel@ksgr.ch


No publications provided by University of Zurich

Publications automatically indexed to this study:

Responsible Party: Räto T. Strebel, Department of Urology, University Hospital Zürich, switzerland
ClinicalTrials.gov Identifier: NCT00831701     History of Changes
Other Study ID Numbers: 1-Hermanns
Study First Received: November 19, 2008
Results First Received: January 11, 2010
Last Updated: May 19, 2010
Health Authority: Switzerland: Ethikkommission