Naloxegol for Opioid-Related Gastroparesis
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|ClinicalTrials.gov Identifier: NCT03036891|
Recruitment Status : Withdrawn
First Posted : January 30, 2017
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis Opioid Use||Drug: Naloxegol 25 MG Oral Tablet [Movantik] Drug: Placebo Oral Tablet||Phase 2|
Medicines can delay gastric emptying and produce similar symptoms to gastroparesis. In particular, narcotic analgesics, can produce a gastroparesis picture, by delaying gastric emptying. The slowing effect of opioids on gastric, small bowel, and colonic motility has been well characterized. Unfortunately, many of these patients cannot stop their pain medications due to their underlying condition, such as back pain, fibromyalgia. On top of this, the narcotics can reduce the effectiveness of prokinetics agents used to treat gastroparesis, such as metoclopramide and domperidone. At this time, there is no good treatment for gastroparesis, especially for opioid-related gastroparesis.
Data suggests a relationship between opioid use and decreased gastric motility. Literature suggests that peripherally acting opioid agonist may provide relief in the instance of GI dysfunction (Holzer 2007). Movantik (Naloxegol) is an opioid agonist specifically designed to work outside of the central nervous system. Movantik (Naloxegol) can alleviate the adverse effects associated in chronic pain patients on opioid treatment - reduction of the undesired peripheral effects of opioids without disrupting analgesic effects. The use of Movantik (Naloxegol) has the potential to improve gastric dysmotility while preserving pain relief of the opioid analgesic.
The objective of this study is to evaluate the effects of naloxegol in opioid-related gastroparesis. This will be a randomized, double-blind study comparing Movantik 25 mg to placebo. The dose of Movantik is the dose that is currently FDA approved for opioid-induced constipation. The four-week study period is the duration of the phase 2b studies for Movantik for opioid-induced constipation in which the response rates were 60% and 35% with active treatment and placebo (Chey 2015).
The investigators have included a unique aspect of this study to better balance the benefits for patients participating in this randomized double-blind study in which half the patients receive a placebo agent. All patients in the treatment group and the placebo group will be invited to participate in the 4-week open-label extension for this study. This also serves to study the duration of the potential favorable effects of Movantik (Naloxegol) in this patient population as well as offering an extended time period to assess safety and tolerability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The investigators have included a unique aspect of this study to better balance the benefits for patients participating in this randomized double-blind study in which half the patients receive a placebo agent. All patients in the treatment group and the placebo group will be invited to participate in the 4-week open-label extension for this study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Naloxegol for Opioid-Related Gastroparesis: A Double-Blind Study With an Open Label Extension|
|Actual Study Start Date :||December 29, 2016|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||September 30, 2019|
Experimental: Study Group
Naloxegol 25 mg, oral tablet, daily for 4 weeks
Drug: Naloxegol 25 MG Oral Tablet [Movantik]
Patients will be given the study drug (Movantik 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
Other Name: Study
Placebo Comparator: Placebo Control
Placebo Oral Tablet, 25 mg, oral tablet, daily for 4 weeks
Drug: Placebo Oral Tablet
Patients will be given Placebo (Placebo 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
Other Name: Control
- Gastric Emptying (GE t-1/2) [ Time Frame: 4 week ]Improvement in gastric emptying (GE t-1/2) compared to Placebo
- Daily Symptom Improvement using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary) [ Time Frame: 4 weeks ]Improvements of gastroparesis symptoms using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary)
- Symptom Improvement using PAGI-SYM [ Time Frame: 4 weeks ]Improvements of gastroparesis symptoms using PAGI-SYM
- Pain Management using the McGill Pain Inventory [ Time Frame: 4 weeks ]Changes in pain control using the McGill Pain Inventory
- Overall improvement in Gastric Emptying (GE t-1/2) [ Time Frame: 8 week ]Improvement in gastric emptying (GE t-1/2) compared to Placebo
- Quality of Life based on SF-36 [ Time Frame: 4 weeks ]QOL score changes based on 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): NCT03036891
|United States, Pennsylvania|
|Lewis Katz School of Medicine at Temple University|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Henry Parkman, MD||Temple University Hospita|