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Comparative Treatment Study in Patients With Lower Ureteral Stones

This study is not yet open for participant recruitment.
Verified by Hillel Yaffe Medical Center, November 2006

Sponsored by: Hillel Yaffe Medical Center
Information provided by: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00397397
  Purpose

We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?


Condition Phase
Urinary Calculi
Phase 0

Drug Information available for:   Alfuzosin    Alfuzosin hydrochloride   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Random Sample, Prospective Study
Official Title:   Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone

Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment:   60
Study Start Date:   January 2007
Estimated Study Completion Date:   March 2007

Detailed Description:

The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Clinical diagnosis of lower ureter (urinary calculi) up to 8mm
  • Must be able to swallow tablets

Exclusion Criteria:

  • Sensitivity to Alfuzosin and Rowatinex
  • Pregnant and breastfeeding women
  • Single kidney
  • Obstructing stone
  • Renal failure creatinine up to 1.8 mg/dl
  • Patients using various alpha blockers
  • Liver failure
  • Fever higher than 38 C
  • UTI
  • Syncope or hypotension
  • Patients treated with PDE5
  • Patients treated with inhibitor CYP3A4
  • Patients refusing participation
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397397

Locations
Israel
Hillel Yaffe Medical Center    
      Hadera, Israel, 38100

Sponsors and Collaborators
Hillel Yaffe Medical Center

Investigators
Principal Investigator:     Gabriel Faragi     Urology Department, Hillel Yaffe Medical Center    
  More Information


Study ID Numbers:   15/2006CTIL
First Received:   November 8, 2006
Last Updated:   November 8, 2006
ClinicalTrials.gov Identifier:   NCT00397397
Health Authority:   Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Urinary Calculi  
Rowatinex  
Alfuzosin  
Drug Therapy  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Ureterolithiasis
Alfuzosin
Urologic Diseases
Urolithiasis
Ureteral Diseases
Ureteral Calculi
Calculi

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008




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