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NCT01539707
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder
Phase 1 trial testing Solifenacin succinate suspension 5 mg in Overactive Bladder in 14 participants. Completed in 13 August 2012.
13 August 2012
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 14 |
| Start date | 13 March 2012 |
| Primary completion | 13 August 2012 |
| Estimated completion | 13 August 2012 |
| Sites | 7 locations across Denmark, Netherlands, Belgium, United Kingdom, Poland, Canada, Turkey (Türkiye) |
Drugs / interventions tested
- Solifenacin succinate suspension 5 mg
Conditions studied
- Overactive Bladder — all drugs for Overactive Bladder →
- Neurogenic Detrusor Overactivity — all drugs for Neurogenic Detrusor Overactivity →
Sponsor
Astellas Pharma Inc — full company profile →
Who can join
Adults 5 to 17, any sex, with Overactive Bladder or Neurogenic Detrusor Overactivity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
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 NCT01539707
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Solifenacin succinate suspension 5 mg
Trials testing the same drug.
- NCT01262391 — Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents · Phase 1 · completed
Other recruiting trials for Overactive Bladder
Currently open trials in the same condition.
- NCT06201013 — Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet · NA · recruiting
- NCT05895045 — Yoga for Treatment of Overactive Bladder in Pediatric Patients · NA · recruiting
- NCT07209397 — Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women · NA · recruiting
- NCT06921746 — Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients · recruiting
- NCT06935240 — Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity · NA · recruiting
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed
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 NCT01539707 (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 Astellas Pharma Inc
- Last refreshed: 22 October 2024
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/NCT01539707.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing