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NCT00388401 · 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
- 510
- Enrollment target
- 1
- Study location
NCT00388401: Completed Phase 3 study of Ileus, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT00388401 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 510 participants, above the 383-participant average among 5 other Ileus trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00388401, 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
- 510 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
- Adolor Corporation - Exton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2002-01 |
| Est. Completion | 2003-06 |
| Phase | Phase 3 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
What the finished NCT00388401 record still lists
NCT00388401 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, above the 383-participant average among 5 other Ileus trials with a reported enrollment target (33% higher).
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.
NCT00388401 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00388401 about?
NCT00388401 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 NCT00388401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2002-01. Estimated completion is 2003-06.
What conditions does trial NCT00388401 study?
This clinical trial studies the following conditions: Ileus.
What interventions are being tested in trial NCT00388401?
The interventions under investigation include: Alvimopan (DRUG).
Who is sponsoring clinical trial NCT00388401?
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 NCT00388401 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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