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NCT00388258 · ClinicalTrials.gov registry record · Phase 3
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
A Phase 3 study of Ileus, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
- 1
- Study location
NCT00388258 is a Phase 3 study of Ileus that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 451 participants, above the 395-participant average among 5 other Ileus trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00388258, a Phase 3 study of Ileus, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).
Conditions Studied
Interventions
- DRUG Alvimopan
Study Locations (1)
Pennsylvania
- Various - Exton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2001-03-01 |
| Est. Completion | 2002-12-01 |
| Phase | Phase 3 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388258
The ClinicalTrials.gov registry entry for NCT00388258 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 451 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 395-participant average among 5 other Ileus trials with a reported enrollment target (14% higher). The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ileus appearing as the primary indexed condition, and to 1 intervention - of which Alvimopan is the first listed.
NCT00388258 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00388258 about?
NCT00388258 is a clinical study titled "Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus". Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatu...
What is the current status of trial NCT00388258?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2001-03-01. Estimated completion is 2002-12-01.
What conditions does trial NCT00388258 study?
This clinical trial studies the following conditions: Ileus.
What interventions are being tested in trial NCT00388258?
The interventions under investigation include: Alvimopan (DRUG).
Who is sponsoring clinical trial NCT00388258?
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.
Where is trial NCT00388258 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
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Read our methodology - how this data is sourced, computed, and verified.
Related
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