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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00451191
The ClinicalTrials.gov registry entry for NCT00451191 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (76% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.