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NCT02097121 · ClinicalTrials.gov registry record · Phase 3
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
A Phase 3 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT02097121 is a Phase 3 study that was terminated before completion, run by Allergan. The registered enrollment target is 56 participants.
The verdict
NCT02097121, a Phase 3 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
Interventions
- BIOLOGICAL BOTOX®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2022-02-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02097121
The ClinicalTrials.gov registry entry for NCT02097121 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BOTOX® is the first listed.
NCT02097121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02097121 about?
NCT02097121 is a clinical study titled "OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)". This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1...
What is the current status of trial NCT02097121?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2014-05-23. Estimated completion is 2022-02-10.
What interventions are being tested in trial NCT02097121?
The interventions under investigation include: BOTOX® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02097121?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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