ISRCTN69423238
Completed
Phase 3
se of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre placebo controlled randomised trial of a calcium channel blocker (nifedipine) and an a blocker (tamsulosin)
niversity of Aberdeen (UK)0 sites1,200 target enrollmentNovember 18, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Aberdeen (UK)
- Enrollment
- 1200
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients presenting acutely with ureteric colic
- •2\. Adults \=18 \= 65 years of age
- •3\. Presence of stone confirmed by non\-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by intravenous urogram (IVU) with subsequent CTKUB confirmation within 12 hours
- •4\. Stone within any segment of the ureter
- •5\. Unilateral ureteric stone
- •6\. Largest stone dimension \=10 mm
- •7\. Female subjects must be post menopausal (defined as 12 months with no menses without an alternative medical cause), permanently sterilised or willing to use two methods of contraception listed in the protocol prior to the start of dosing until at least 28 days after receiving the last dose of trial medication
- •8\. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion Criteria
- •1\. Women who have a known or suspected pregnancy
- •2\. Women who are breastfeeding
- •3\. Asymptomatic incidentally found ureteric stone
- •4\. Stone not confirmed by CTKUB
- •5\. Stone with any one dimension \>10 mm
- •6\. Kidney stone without the presence of ureteric stone
- •7\. Multiple (i.e. \= 2\) stones within ureter
- •8\. Bilateral ureteric stones
- •9\. Stone in a ureter draining a solitary kidney (either anatomically or functionally)
- •10\. Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit)
Outcomes
Primary Outcomes
Not specified
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