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NCT03216525 · ClinicalTrials.gov registry record · Phase 3
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
A Phase 3 study of Bladder Cancer, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
- 1
- Study location
NCT03216525 is a Phase 3 study of Bladder Cancer that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 136 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03216525, a Phase 3 study of Bladder Cancer, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Alvimopan
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2024-06-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03216525
The ClinicalTrials.gov registry entry for NCT03216525 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03216525 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03216525 about?
NCT03216525 is a clinical study titled "Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol". To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.
What is the current status of trial NCT03216525?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2018-10-01. Estimated completion is 2024-06-01.
What conditions does trial NCT03216525 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT03216525?
The interventions under investigation include: Placebo (DRUG), Alvimopan (DRUG).
Who is sponsoring clinical trial NCT03216525?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03216525 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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