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NCT00824200 · ClinicalTrials.gov registry record · Phase 4
Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)
A Phase 4 study, sponsored by Atlanta VA Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT00824200 is a Phase 4 study that has completed, run by Atlanta VA Medical Center. The registered enrollment target is 72 participants.
The verdict
NCT00824200, a Phase 4 study, has completed, sponsored by Atlanta VA Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study Summary
Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications. Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months. This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.
Interventions
- DRUG placebo
- BEHAVIORAL Behavioral
- BEHAVIORAL placebo
- DRUG tamsulosin (alpha-adrenergic antagonist medication)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2008-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00824200
The ClinicalTrials.gov registry entry for NCT00824200 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlanta VA Medical Center, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00824200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00824200 about?
NCT00824200 is a clinical study titled "Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)". Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be u...
What is the current status of trial NCT00824200?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2008-07. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00824200?
The interventions under investigation include: placebo (DRUG), Behavioral (BEHAVIORAL), placebo (BEHAVIORAL), tamsulosin (alpha-adrenergic antagonist medication) (DRUG).
Who is sponsoring clinical trial NCT00824200?
This trial is sponsored by Atlanta VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.
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