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NCT00388479 · ClinicalTrials.gov registry record · Phase 3
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus
A Phase 3 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 3
- Development phase
- 666
- Enrollment target
NCT00388479 is a Phase 3 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 666 participants.
The verdict
NCT00388479, a Phase 3 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 666 participants
- Enrollment target
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 and 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).
Interventions
- DRUG Alvimopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2001-12 |
| Est. Completion | 2003-11 |
| Phase | Phase 3 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388479
The ClinicalTrials.gov registry entry for NCT00388479 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Alvimopan is the first listed.
NCT00388479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00388479 about?
NCT00388479 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 and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass fl...
What is the current status of trial NCT00388479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2001-12. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00388479?
The interventions under investigation include: Alvimopan (DRUG).
Who is sponsoring clinical trial NCT00388479?
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.
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