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NCT03852524 · ClinicalTrials.gov registry record · Phase 2

Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

A Phase 2 study, sponsored by Ohio State University.

Completed
Registry status
Phase 2
Development phase
82
Enrollment target

NCT03852524 is a Phase 2 study that has completed, run by Ohio State University. The registered enrollment target is 82 participants.

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The verdict

NCT03852524, a Phase 2 study, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
Phase 2
Development phase
82 participants
Enrollment target

Study Summary

This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing narcotic usage or otherwise disrupting the recovery course of patients. Using a double-blind randomized design, either subcutaneous MNTX (0.15 mg/kg rounded to 8 mg or 12 mg) or placebo will be administered starting before surgery and then daily for three days. Information will be collected from medical records in IHIS up to 30 days prior to surgery and then for up to 30 days after surgery.

Interventions

  • OTHER Placebo
  • DRUG Methylnaltrexone

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2019-02-21
Est. Completion 2021-05-12
Phase Phase 2

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT03852524

The ClinicalTrials.gov registry entry for NCT03852524 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03852524 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03852524 about?

NCT03852524 is a clinical study titled "Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention". This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing narcotic usage or otherwise disrupting the recovery course of patients. Usin...

What is the current status of trial NCT03852524?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2019-02-21. Estimated completion is 2021-05-12.

What interventions are being tested in trial NCT03852524?

The interventions under investigation include: Placebo (OTHER), Methylnaltrexone (DRUG).

Who is sponsoring clinical trial NCT03852524?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

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.