E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy. |
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E.1.1.1 | Medical condition in easily understood language |
insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046707 |
E.1.2 | Term | Urolithiasis |
E.1.2 | System Organ Class | 100000004857 |
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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 study’s primary objective is to evaluate the efficacy of Mirabegron in decreasing JJ- related LUTS for urolithiasis when compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
The study’s secondary objective is to evaluate if there is an improvement in health related quality of life (HRQoL) of treatment with Mirabegron versus placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subject is male or female and at least 18 years of age; • IEC/IRB -approved written Informed Consent (IC) and privacy language as per national regulations has been obtained from the subject or legally authorized representative prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); • Female subject who is of childbearing potential* must have a negative urine pregnancy test at screening and must be using highly effective contraception. • Female subject must not be breastfeeding at Screening or during the study period and for 28 days after final IMP administration; • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final IMP administration; • Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at Screening and continue throughout the study period and for 90 days after final IMP administration; • Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final IMP administration; • Insertion of the same JJ Stent (Percuflex, Boston Scientific, 4.8 Fr, 26 cm) • No history of JJ stent insertion • Estimated duration of stenting: 2 weeks * A female subject is either: • Of non-childbearing potential: - Post-menopausal (defined as at least 1 year without any menses) prior to registration or - Documented surgically sterile (at least 1 month prior to registration or status post hysterectomy) • Or, if of childbearing potential, - Must have a negative urine pregnancy test prior study registration - Must use effective form of birth control throughout the study.
Acceptable forms of birth control include: - established use of oral, injected or implanted hormonal methods of contraception - placement of an intrauterine device (IUD) or intrauterine system (IUS) - barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/suppository)
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E.4 | Principal exclusion criteria |
• Bilateral ureteral stents to be inserted • JJ stent already in situ prior to ureteroscopy • Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc) • Patients with urinary diversion • Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder. • Indwelling foley catheter • Urinary tract infection (urinalysis) • Patients currently taking antimuscarinics, Mirabegron, or α-blockers • Patients with contraindications to receive Mirabegron (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection • Suspected or confirmed ureteral perforation • Placement of a JJ stent after an open procedure • Uncontrolled Hypertension (SBP≥180 mmHg and/or DBP≥110mmHg) • Patients with severe renal impairment concomitantly receiving strong CYP3A inhibitors • Patients with severe hepatic impairment and patients with moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors • Patients with Bladder Outlet Obstruction (BOO) • Patients with hypersensitivity in Mirabegron or to any of the following excipients: polyethyleneglycols, butylhydroxytoluene, magnesium stearate, hypromellose, Iron oxide yellow (E172) • Participation in another interventional study one month before inclusion of the patient in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference between the two arms in the average urinary symptoms score of visits 2 and 3 as reported in the Ureteral Stent Symptom Questionnaire (USSQ). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of subjects' follow up |
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E.5.2 | Secondary end point(s) |
1. Difference between the two arms in the urinary symptoms score of visit 2 as reported in the USSQ. 2. Difference between the two arms in the urinary symptoms score of visit 3 as reported in the USSQ. 3. Difference between the two arms in the average score of visits 2 and 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index). 4. Difference between the two arms in the score of visit 2 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index). 5. Difference between the two arms in the score of visit 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index). 6. Difference between the two arms in the average daily VAS measurements. 7. Difference between the two arms in the average VAS measurements of the period between visit2 and visit 3. 8. Difference between the two arms in the number of days for duration of JJ stent in situ. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of subjects' follow up |
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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 | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 15 |