Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01767519 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT01767519: Completed Phase 3 study, sponsored by Allergan.
NCT01767519 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 356 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767519, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.
Primary Outcome
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Interventions
- DRUG solifenacin
- BIOLOGICAL BOTOX®
- DRUG Botox placebo (normal saline)
- DRUG solifenacin placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2013-03-01 |
| Est. Completion | 2015-03-18 |
| Phase | Phase 3 |
What the finished NCT01767519 record still lists
NCT01767519 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which solifenacin is the first listed.
NCT01767519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01767519 about?
NCT01767519 is a clinical study titled "A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence". A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.
What is the current status of trial NCT01767519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2013-03-01. Estimated completion is 2015-03-18.
What interventions are being tested in trial NCT01767519?
The interventions under investigation include: solifenacin (DRUG), BOTOX® (BIOLOGICAL), Botox placebo (normal saline) (DRUG), solifenacin placebo (DRUG).
Who is sponsoring clinical trial NCT01767519?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01767519's enrollment target sits among peer trials
356 1024th of 2000 higher than 976 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06077838 · 356 participants · NA
RELAXaHEAD for Headache Patients (Phase III)
- NCT06293469 · 356 participants · NA
Accelerated Flap Coverage in Severe Lower Extremity Trauma
- NCT06958328 · 356 participants · Phase 3
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
- NCT06960993 · 356 participants · NA
Mosaic Trial for Stem Cell Transplant Recipients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI