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NCT01589263 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01589263: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01589263 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01589263, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life significantly, and are costly. his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled, parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS \[American Urologic Association Symptom Score (AUASS) equal to or greater than 8\] associated with BPH. A total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers will include only males who are greater than 50 years of age and diagnosed with LUTS associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or ethnicity.
Primary Outcome
AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome.
Interventions
- DRUG onaBoNT-A + placebo
- DRUG Tamsulosin + placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-06-01 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
What the finished NCT01589263 record still lists
NCT01589263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which onaBoNT-A + placebo is the first listed.
NCT01589263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01589263 about?
NCT01589263 is a clinical study titled "Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS". Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life significantly, and are costly. his...
What is the current status of trial NCT01589263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2012-06-01. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT01589263?
The interventions under investigation include: onaBoNT-A + placebo (DRUG), Tamsulosin + placebo (DRUG).
Who is sponsoring clinical trial NCT01589263?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01589263's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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