E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Use 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). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of the project is to determine the clinical effectiveness and cost-effectiveness of the use of an alpha blocker(tamsulosin) and a calcium channel blocker (nifedipine) in the management of symptomatic urinary stones.
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E.2.2 | Secondary objectives of the trial |
In the context of all patients receiving current standard care two pragmatic comparisons will be made evaluating medical expulsive therapies (MET) for facilitating ureteric stone passage: 1) MET (Alpha blocker [tamsulosin] or Calcium channel blocker [nifedipine]) versus placebo: and 2) Alpha blocker (tamsulosin) versus Calcium channel blocker (nifedipine).
The hypotheses being tested are: 1) The use of MET will result in an absolute increase in the spontaneous stone passage rate of at least 25% compared with placebo and, 2) The use of an alpha blocker (tamsulosin) will result in an absolute increase of 10% in the spontaneous stone passage rate compared with a calcium channel blocker (nifedipine).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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) • Presence of urinary sepsis • Chronic kidney disease renal failure stage 4 or stage 5 (eGFR < 30ml/min) • Patients currently taking an α-blocker • Patients currently taking a calcium channel blocker • Patients currently taking PDE5 inhibitors • Contraindication or allergy to tamsulosin or nifedipine • Patients who are unable to understand or complete trial documentation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcomes: 1) The primary outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage); 2) Incremental cost per quality adjusted life years (QALY) at 3 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial for each participant will be defined as 18 weeks post randomisation to allow for collection of the 12 week questionnaire. End of trial is when the last participant randomised reaches this 18 week timepoint. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |