A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00489112

Distal Ureterolithiasis

UNKNOWN PHASE4

Use of Alfuzosin in Stone Treatment With ESWL

NCT00388271

Urinary Calculi

WITHDRAWN PHASE3

ALF-STONE: Alfuzosin in Uretheric Stones

NCT00454402

Prostatic Hyperplasia

TERMINATED PHASE3

Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

NCT00713739

Kidney Stones

UNKNOWN PHASE3

Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

NCT00177086

Kidney Calculi Ureteral Calculi Colic

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Stones

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Alfuzosin (Xatral)

Intervention Type DRUG

10 mg PO once a day

B

Group Type PLACEBO_COMPARATOR

Placebo Alfuzosin

Intervention Type DRUG

10 mg PO once a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alfuzosin (Xatral)

10 mg PO once a day

Intervention Type DRUG

Placebo Alfuzosin

10 mg PO once a day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
* stone radiopaque on KUB, distal to the sacro-iliac joint
* patient suitable for discharge from ER
* patient willing to return for follow-up on a weekly basis for maximum 4 visits

Exclusion Criteria

* more than one ureteral calculi
* radiolucent stones or cystine stones
* prior ipsilateral calculus or ureteral surgery
* congenital anomalies of the ureter
* patients presents with an absolute indication for intervention
* allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP \<90 mmHg)
* patient currently taking an alpha-blocker
* hepatic insufficiency
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No