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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 is a Phase 2 study that was terminated before completion, run by Temple University. The registered enrollment target is 2 participants.
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
Interventions
- DRUG Placebo Oral Capsule
- DRUG Naloxegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02998606
The ClinicalTrials.gov registry entry for NCT02998606 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Capsule is the first listed.
NCT02998606 reports 0 study locations.
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.
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