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

NCT00489112 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2007-06-26

No results posted yet for this study

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.

Conditions

  • Distal Ureterolithiasis

Interventions

DRUG

Alfuzocine XL 10 mg once a day

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • doron perez, M.D. · HaEmek MC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

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View NCT00489112 on ClinicalTrials.gov