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NCT01258569 · ClinicalTrials.gov registry record · Phase 2
Entereg Laparoscopic Colon Resection Study
A Phase 2 study of Laparoscopic Colonic Resection, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 1
- Study location
NCT01258569 is a Phase 2 study of Laparoscopic Colonic Resection that has completed, run by Hartford Hospital. The registered enrollment target is 135 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01258569, a Phase 2 study of Laparoscopic Colonic Resection, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use Utilization Evaluation studies reporting results involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study will be the first randomized, prospective, double-blind, placebo-controlled trial looking at this population. We propose that Entereg will decrease the length of stay by one day in the laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be secondary endpoints. Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date: May 2012, Estimated Primary Completion Date: Nov 2011.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Entereg
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01258569
The ClinicalTrials.gov registry entry for NCT01258569 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Laparoscopic Colonic Resection appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01258569 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT01258569 about?
NCT01258569 is a clinical study titled "Entereg Laparoscopic Colon Resection Study". Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use U...
What is the current status of trial NCT01258569?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2010-11. Estimated completion is 2015-07.
What conditions does trial NCT01258569 study?
This clinical trial studies the following conditions: Laparoscopic Colonic Resection.
What interventions are being tested in trial NCT01258569?
The interventions under investigation include: placebo (DRUG), Entereg (DRUG).
Who is sponsoring clinical trial NCT01258569?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01258569 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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