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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: Recruiting Phase 3 study of Bladder Cancer, sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = \[first toleration of solid food\] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, 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 |
What NCT03216525 shows while recruiting
NCT03216525 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03216525's enrollment target sits among peer trials
136 73rd of 175 higher than 103 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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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