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NCT02998606 · ClinicalTrials.gov registry record · Phase 2

Movantik for Opioid-Related Esophageal Disorders

A Phase 2 study, sponsored by Temple University.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT02998606: Clinical Trial Phase 2 study, sponsored by Temple University.

NCT02998606 is a Phase 2 study that was terminated before completion, run by Temple University. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02998606, a Phase 2 study, was terminated before completion, sponsored by Temple University.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

To date, few studies have assessed the effect of opioids on esophageal motility, mostly assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a large retrospective study assessing the effect of opioids on esophageal motility found that esophageal motor dysfunction are common in chronic opioid users whether studied on opioids and off opioids. In addition, current opioid users also had significantly higher integrated relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli 2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose, MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is associated with preservation of centrally mediated analgesia. This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient population. The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced esophageal motility disorders

Primary Outcome

The effect of MOVANTIK™ (Naloxegol) on motor function, categorized as a 25% (mmHg) improvement in IRP (Integrated Relaxation Pressure) on high resolution esophageal manometry from baseline to visit three, comparing study group to placebo control group.

Interventions

  • DRUG Placebo Oral Capsule
  • DRUG Naloxegol

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2017-01
Est. Completion 2018-10
Phase Phase 2
Temple University

163 total trials

Why NCT02998606 stopped before completion

NCT02998606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT02998606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02998606 about?

NCT02998606 is a clinical study titled "Movantik for Opioid-Related Esophageal Disorders". To date, few studies have assessed the effect of opioids on esophageal motility, mostly assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a large retrospective study assessing the effect of opioids on esophageal motility found that esophageal motor dysfunction ...

What is the current status of trial NCT02998606?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2017-01. Estimated completion is 2018-10.

What interventions are being tested in trial NCT02998606?

The interventions under investigation include: Placebo Oral Capsule (DRUG), Naloxegol (DRUG).

Who is sponsoring clinical trial NCT02998606?

This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02998606's enrollment target sits among peer trials

2 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02998606, the US trial registry maintained by the National Library of Medicine. NCT02998606 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.