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NCT02946580 · ClinicalTrials.gov registry record · Phase 4
Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT02946580: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02946580 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02946580, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.
Primary Outcome
The primary endpoint of the study was time to first post-operative bowel movement, as defined by the first spontaneous bowel movement reported by nursing staff after transfer from the surgical suite to the inpatient floor. A bowel movement was defined as the spontaneous passage of one tablespoon or more of liquid or solid stool (excluding flatus), which could be measured and verified by nursing staff. Time was measured in hours post-operatively with the starting time point marked at the end of t
Interventions
- DRUG Sugar Pill
- DRUG MOVANTIK™ (naloxegol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-02 |
| Phase | Phase 4 |
Why NCT02946580 stopped before completion
NCT02946580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Sugar Pill is the first listed.
NCT02946580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02946580 about?
NCT02946580 is a clinical study titled "Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients". Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a F...
What is the current status of trial NCT02946580?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2017-01. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02946580?
The interventions under investigation include: Sugar Pill (DRUG), MOVANTIK™ (naloxegol) (DRUG).
Who is sponsoring clinical trial NCT02946580?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02946580's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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