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NCT00205842 · 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
660
Enrollment target
1
Study location

NCT00205842 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 660 participants, above the 353-participant average among 5 other Ileus trials with a reported enrollment target (87% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00205842, 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
660 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 and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.

Conditions Studied

Interventions

  • DRUG alvimopan

Study Locations (1)

Pennsylvania

  • 50 Sites - Exton

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2004-06
Est. Completion 2005-12
Phase Phase 3

What the Registry Record Tells You About NCT00205842

The ClinicalTrials.gov registry entry for NCT00205842 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 353-participant average among 5 other Ileus trials with a reported enrollment target (87% 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.

NCT00205842 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00205842 about?

NCT00205842 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; variable reduction of bowel sounds; del...

What is the current status of trial NCT00205842?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2004-06. Estimated completion is 2005-12.

What conditions does trial NCT00205842 study?

This clinical trial studies the following conditions: Ileus.

What interventions are being tested in trial NCT00205842?

The interventions under investigation include: alvimopan (DRUG).

Who is sponsoring clinical trial NCT00205842?

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 NCT00205842 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.