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Comparative Treatment Study in Patients With Lower Ureteral Stones

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00397397
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Alfuzosin
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013