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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01589263
The ClinicalTrials.gov registry entry for NCT01589263 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which onaBoNT-A + placebo is the first listed.
NCT01589263 reports 0 study locations.
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.
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