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| Sponsor: | Soroka University Medical Center |
|---|---|
| Information provided by: | Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00451061 |
Purpose
Most of the patients suffering from renal colic have a distal ureterolithiasis. It had been demonstrated that α adrenoreceptors antagonists, given to patients suffering from renal colic, due to distal ureterolithiasis, had increased the frequency of stone expulsion rate , reduced the time to expulsion and reduced analgesics consumption.Most of the studies evaluated the efficacy of Tamsulosin, which is a selective α 1A and α 1D adrenoreceptors antagonist.(The lower intramural portion of the ureter, where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors)
Only one study these days describes the use of Alfuzosin, which is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor, for expulsion of distal ureteric stones.Alfuzosin is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity, for the treatment of BPH. There was no significant difference in efficacy between the two α blockers (Alfuzosin vs. Tamsulosin) concerning symptoms relief or flow improvement.
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis (analgesics, Rowatinex) to patients who would receive also a non selective α blocker (Alfuzosin) or a selective α blocker (Tamsulosin). This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Colic |
Drug: Alfuzosin Drug: Tamsulosin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• renal colic due to radiologically proven distal ureteral stones
Exclusion Criteria:
Contacts and Locations| Contact: Eran Rosenberg, M.D | 972-8-6400626 | eranro@clalit.org.il |
| Israel | |
| Urology department, Soroka university medical center | Not yet recruiting |
| Beer-Sheva, p,o,box 151, Israel, 84101 | |
| Principal Investigator: | Eran Rosenberg, M.D | Soroka university medical center, Beer-Sheva, Israel |
| Study Director: | Igor Romanowski, M.D | Soroka university medical center, Beer-Sheva, Israel |
More Information
| ClinicalTrials.gov Identifier: | NCT00451061 History of Changes |
| Other Study ID Numbers: | sor449907ctil |
| Study First Received: | March 21, 2007 |
| Last Updated: | April 26, 2007 |
| Health Authority: | Israel: Ministry of Health |
|
distal ureterolithiasis α adrenoreceptors antagonist |
|
Renal Colic Colic Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive Alfuzosin Tamsulosin Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |