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NCT00451191 · ClinicalTrials.gov registry record · Phase 2
Botulinum Toxin Injection for the Management of BPH
A Phase 2 study of Benign Prostatic Hyperplasia, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 7
- Study locations
NCT00451191: Completed Phase 2 study of Benign Prostatic Hyperplasia, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00451191 is a Phase 2 study of Benign Prostatic Hyperplasia that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 134 participants, below the 547-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (76% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451191, a Phase 2 study of Benign Prostatic Hyperplasia, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.
Primary Outcome
The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) \>=40% of the participants reported a moderat
Conditions Studied
Interventions
- DRUG botulinum toxin type A (BoNT/A)
Study Locations (7)
Texas
- University of Texas Southwestern Medical Center - Dallas
- Baylor College of Medicine - Houston
Colorado
- University of Colorado Health Sciences Center - Denver
Illinois
- Northwestern University - Chicago
Minnesota
- Mayo Clinic - Rochester
New York
- Cornell University - New York
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00451191 record still lists
NCT00451191 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 547-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 1 intervention - of which botulinum toxin type A (BoNT/A) is the first listed.
NCT00451191 lists 7 locations in 6 states (Texas, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT00451191 about?
NCT00451191 is a clinical study titled "Botulinum Toxin Injection for the Management of BPH". This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 3...
What is the current status of trial NCT00451191?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2006-10. Estimated completion is 2009-12.
What conditions does trial NCT00451191 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT00451191?
The interventions under investigation include: botulinum toxin type A (BoNT/A) (DRUG).
Who is sponsoring clinical trial NCT00451191?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00451191 being conducted?
This trial has 7 study locations across Colorado, Illinois, Minnesota, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00451191's enrollment target sits among peer trials
134 16th of 29 higher than 14 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia 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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