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NCT00708201 · ClinicalTrials.gov registry record · Phase 4
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
A Phase 4 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 4
- Development phase
- 280
- Enrollment target
NCT00708201: Completed Phase 4 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT00708201 is a Phase 4 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 280 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00708201, a Phase 4 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 280 participants
- Enrollment target
Study Summary
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: * to evaluate the effect of alvimopan on hospital length of stay * to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities * to evaluate the overall and cardiovascular safety of alvimopan
Primary Outcome
Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement \[BM\]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for
Interventions
- DRUG Placebo
- DRUG Alvimopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-01 |
| Phase | Phase 4 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
What the finished NCT00708201 record still lists
NCT00708201 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00708201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00708201 about?
NCT00708201 is a clinical study titled "A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy". This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: * to evaluate the effect of alvimopan on hospital length of stay * to evaluate the effe...
What is the current status of trial NCT00708201?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 280 participants. The study started on 2009-03. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00708201?
The interventions under investigation include: Placebo (DRUG), Alvimopan (DRUG).
Who is sponsoring clinical trial NCT00708201?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00708201's enrollment target sits among peer trials
280 303rd of 2000 higher than 1,696 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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