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The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study

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ClinicalTrials.gov Identifier: NCT00489112
Recruitment Status : Unknown
Verified June 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : June 21, 2007
Last Update Posted : June 26, 2007
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:
We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.

Condition or disease Intervention/treatment Phase
Distal Ureterolithiasis Drug: Alfuzocine XL 10 mg once a day Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Stone in the distal ureter until 1 cm of diameter

Exclusion Criteria:

  • Evidence of urinary tract infection or sepsis
  • Moderate or severe hydronephrosis
  • Acute renal failure
  • Ureteral stricture
  • Stone with >1cm of diameter
  • Previuos use of alpha blocker
  • Pregnancy
  • Previuos ureteral endoscopic or open surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489112


Contacts
Contact: DORON PEREZ, M.D. +972-4-6495115 perez_do@clalit.org.il

Locations
Israel
Haemek medical center,urology department Not yet recruiting
Afula, Israel, 18100
Contact: doron perez, M.D.    +972-4-6495115    perez_do@clalit.org.il   
Haemek Medical Center Recruiting
Afula, Israel, 18100
Contact: doron perez, MD    +972-4-6495115    perez_do@clalit.org.il   
Principal Investigator: doron perez, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: doron perez, M.D. HaEmek MC

ClinicalTrials.gov Identifier: NCT00489112     History of Changes
Other Study ID Numbers: 0044-07-EMC
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Ureterolithiasis
Ureteral Calculi
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical