Last reviewed · How we verify
NCT01178827
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Phase 4 trial testing trospium chloride in Overactive Bladder in 20 participants. Completed in 1 March 2011.
1 March 2011
Quick facts
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 August 2010 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 March 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- trospium chloride — full drug profile →
- oxybutynin IR — full drug profile →
- oxybutynin IR placebo
Conditions studied
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Allergan — full company profile →
Who can join
60 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Time frame: Day 10 Post-Dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. -
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Time frame: Day 2 Post-Dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Sponsor's own description
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
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 NCT01178827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Allergan trials
Trials by the same sponsor.
- NCT04609020 — Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment · Phase 4 · completed
- NCT05452070 — A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft · Phase 3 · completed
- NCT05393089 — Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopi · Phase 2 · withdrawn
- NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
- NCT05088980 — Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbita · 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 NCT01178827 (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 Allergan
- Last refreshed: 28 January 2016
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/NCT01178827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing