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NCT02106182: BPH
Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
Phase 4 trial testing Silodosin in Nocturia in 135 participants. Completed in 1 August 2016.
2 March 2016
Quick facts
| Lead sponsor | JW Pharmaceutical |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 2 January 2014 |
| Primary completion | 2 March 2016 |
| Estimated completion | 1 August 2016 |
| Sites | 6 locations across South Korea |
Drugs / interventions tested
- Silodosin (SILODOSIN) — full drug profile →
- Laboratory tests
- 3-days voiding diary
- 12 weeks
Conditions studied
- Nocturia — all drugs for Nocturia →
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
Sponsor
JW Pharmaceutical — full company profile →
Who can join
50 and older, male only, with Nocturia or Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02106182
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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 Nocturia
Currently open trials in the same condition.
- NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
- NCT06866834 — Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urina · recruiting
- NCT06091566 — Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) · NA · recruiting
- NCT05874375 — UCon Treatment of Overactive Bladder (OAB) in Males · NA · recruiting
- NCT05604222 — Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women · Phase 4 · recruiting
Other JW Pharmaceutical trials
Trials by the same sponsor.
- NCT07514780 — To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers · Phase 1 · not yet recruiting
- NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia · Phase 3 · recruiting
- NCT07374406 — To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers · Phase 1 · recruiting
- NCT07442006 — Glycemic Variability of Combination Therapies in T2DM · Phase 4 · recruiting
- NCT07036458 — To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects · Phase 1 · active not recruiting
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 NCT02106182 (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 JW Pharmaceutical
- Last refreshed: 10 March 2017
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/NCT02106182.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing