Movantik for Opioid-Related Esophageal Disorders
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|ClinicalTrials.gov Identifier: NCT02998606|
Recruitment Status : Terminated (Investigator left Institution)
First Posted : December 20, 2016
Last Update Posted : December 24, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Induced Disorders Esophagus Disorder||Drug: Naloxegol Drug: Placebo Oral Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Movantik for Opioid-Related Esophageal Disorders|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Experimental: Study Group
MOVANTIK™ (Naloxegol) 25 mg oral capsule, daily
MOVANTIK™ 25 mg, daily
Other Name: Movantik
Placebo Comparator: Control Group
Placebo Oral Capsule 25 mg, daily
Drug: Placebo Oral Capsule
Placebo 25 mg, daily
Other Name: Placebo
- Manometric improvement in IRP (Integrated Relaxation Pressure) [ Time Frame: 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.
- Overall Symptom Management [ Time Frame: 28 days ]Mean change from baseline to visit three in subject esophageal symptom scores according to the PAGI-SYM.
- Pain Management [ Time Frame: 28 days ]Mean change from baseline to visit three in subject esophageal symptom scores according to the McGill pain inventory.
- GERD Symptom Management [ Time Frame: 28 days ]Mean change from baseline to visit three in subject esophageal symptom scores according to the GERD symptom check list.
- Chest Pain Management [ Time Frame: 28 days ]Mean change from baseline to visit three in subject esophageal symptom scores according to the chest pain symptom questionnaire.
- Daily Symptom Management [ Time Frame: 28 days ]Mean change from baseline to visit three in subject esophageal symptom scores according to the daily diary
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: 42 days ]The occurrence of adverse events and early withdrawal in study group when compared to placebo control group to determine safety and tolerability.
- Quality of Life [ Time Frame: 28 days ]Mean change in patient-reported quality of life according to the SF-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998606
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Ron Schey, MD||Temple University|