Who is sponsoring NCT02998606?

NCT02998606 is sponsored by Temple University.

What condition does NCT02998606 study?

NCT02998606 studies Opioid-Induced Disorders, Esophagus Disorder.

What drugs are being tested in NCT02998606?

Interventions: Naloxegol, Placebo Oral Capsule.

What is the status of NCT02998606?

NCT02998606 is currently TERMINATED.

Last reviewed 2018-12-20 · How we verify

Movantik for Opioid-Related Esophageal Disorders

NCT02998606 Phase 2 TERMINATED

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

Details

Lead sponsor	Temple University
Phase	Phase 2
Status	TERMINATED
Enrolment	2
Start date	2017-01
Completion	2018-10

Conditions

Opioid-Induced Disorders
Esophagus Disorder

Interventions

Naloxegol
Placebo Oral Capsule

Primary outcomes

Manometric improvement in IRP (Integrated Relaxation Pressure) — 28 days
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.

Countries

United States