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

June 19, 2007
June 25, 2007
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Complete list of historical versions of study NCT00489112 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Distal Ureterolithiasis
Drug: Alfuzocine XL 10 mg once a day
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
Both
18 Years to 80 Years
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Contact: DORON PEREZ, M.D. +972-4-6495115 perez_do@clalit.org.il
Israel
 
NCT00489112
0044-07-EMC
Yes
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HaEmek Medical Center, Israel
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Principal Investigator: doron perez, M.D. HaEmek MC
HaEmek Medical Center, Israel
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP