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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00489112
First received: June 19, 2007
Last updated: June 25, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Distal Ureterolithiasis
Drug: Alfuzocine XL 10 mg once a day
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by HaEmek Medical Center, Israel:

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489112

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00489112     History of Changes
Other Study ID Numbers: 0044-07-EMC
Study First Received: June 19, 2007
Last Updated: June 25, 2007
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014