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NCT05570084
Silodosin vs Tamsulosin as MET
Phase 3 trial testing Silodosin in Stone, Urinary in 80 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | Princess Margaret Hospital, Hong Kong |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 31 May 2022 |
| Primary completion | 30 June 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Silodosin (SILODOSIN) — full drug profile →
- Tamsulosin (tamsulosin) — full drug profile →
Conditions studied
- Stone, Urinary — all drugs for Stone, Urinary →
Sponsor
Princess Margaret Hospital, Hong Kong
Who can join
18 and older, any sex, with Stone, Urinary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones \>5mm. However there is heterogeneity in different alpha blockers. Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin. Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population. The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05570084
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Related trials
Other trials of Silodosin
Trials testing the same drug.
- NCT07467343 — Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial · Phase 4 · not yet recruiting
- NCT06114979 — Silodosin vs Placebo in the Treatment of Female LUTS · Phase 3 · unknown
- NCT06999135 — Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones · NA · completed
- NCT06381206 — Silodosin in Management of Lower Ureteral Stones · Phase 1, PHASE2 · completed
- NCT05790902 — COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI · Phase 1 · completed
Other recruiting trials for Stone, Urinary
Currently open trials in the same condition.
- NCT07306819 — Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy Wit · NA · recruiting
- NCT07052188 — Effect of Preop Stent Duration on SFR and Secondary Intervention in RIRS · NA · active not recruiting
Other Princess Margaret Hospital, Hong Kong trials
Trials by the same sponsor.
- NCT07451548 — RCT on Running Water Sound During Urodynamic · NA · recruiting
- NCT06641804 — Vaginal Prolapse Pessary Material Trial PVC vs Silicon · NA · not yet recruiting
- NCT04461574 — Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05570084 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Princess Margaret Hospital, Hong Kong
- Last refreshed: 6 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05570084.
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