NCT03588806

Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Ajay Wasan, MD, Msc · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will examine how the use of Xtampza ER, an opioid analgesic packaged in openable microsphere-containing capsules, affects swallowing satisfaction, pain, and physical and mental health outcomes in chronic pain patients.

Detailed description

An important step in the evolution of pain care is more personalized medicine. One aspect of personalized medicine emphasizes that patients often have additional requirements for prescription medicines beyond just pain relief, including ease in taking medications and overall satisfaction with their care. Surveys indicate that 20% of adult patients either with or without pain have difficulty swallowing their medications, and up to 10% refuse to take a specific therapy because they cannot swallow the pills \[1-3\]. It is likely that this issue compromises the quantity, quality, and satisfaction with pain relief from oral opioids. Xtampza ER is an opioid analgesic consisting of a microsphere-containing capsule that can be opened so the microspheres can be added to soft food. This drug is designed to overcome capsule-swallowing issues and therefore may be an important tool for personalized pain medicine care. This study will investigate the pharmaceutic delivery properties of Xtampza to determine whether it is an improved alternative to the pill-swallowing problems that are common with opioid drugs.

Conditions

• Chronic Pain
• Opioid Use
• Deglutition

Interventions

Type	Name	Description
DRUG	Xtampza ER (oxycodone)	Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-07-31
• Completion: 2019-10-31
• First posted: 2018-07-17
• Last updated: 2020-06-17
• Results posted: 2020-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study