Distal Ureterolithiasis Clinical Trial
| NCT number | NCT00489112 |
| Other study ID # | 0044-07-EMC |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 4 |
| First received | June 19, 2007 |
| Last updated | June 25, 2007 |
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.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Israel | Haemek Medical Center | Afula | |
| Israel | Haemek medical center,urology department | Afula |
| Lead Sponsor | Collaborator |
|---|---|
| HaEmek Medical Center, Israel |
Israel,