Skip to main content
Clinical Trials/EUCTR2010-019469-26-GB
EUCTR2010-019469-26-GB
Active, not recruiting
Phase 1

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 alpha blocker(tamsulosin) - The SUSPEND trial - Symptomatic ureteric stone passage enabled by drugs (SUSPEND)

niversity of Aberdeen0 sites1,167 target enrollmentJune 18, 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
se of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: multicentre placebo controlled randomised trial of a calcium channel blocker(nifedipine) and an alpha blocker (tamsulosin).
Sponsor
niversity of Aberdeen
Enrollment
1167
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2010
End Date
April 24, 2014
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity of Aberdeen

Eligibility Criteria

Inclusion Criteria

  • Patients presenting acutely with ureteric colic
  • Adults \=18 to \= 65 years of age
  • Presence of stone confirmed by non\-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by IVU (intravenous urogram) with subsequent CTKUB confirmation within 12 hours
  • Stone within any segment of the ureter
  • Unilateral ureteric stone
  • Largest dimension of the stone \=10 mm
  • 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
  • Capable of giving written informed consent, which includes compliance with the requirements of the trial
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:

Exclusion Criteria

  • Women who have a known or suspected pregnancy (confirmed by a pregnancy test)
  • Women who are breast\-feeding
  • Asymptomatic incidentally found ureteric stone
  • Stone not confirmed by CTKUB
  • Stone with any one dimension \>10 mm
  • Kidney stone without the presence of ureteric stone
  • Multiple (i.e. \= 2\) stones within ureter
  • Bilateral ureteric stones
  • Stone in a ureter draining a solitary kidney (either anatomically or functionally)
  • Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit)

Outcomes

Primary Outcomes

Not specified

Similar Trials