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Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

Primary Purpose

Chronic Pain, Opioid Use, Deglutition

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Xtampza ER (oxycodone)

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Abuse-deterrent opioid drugs, Xtampza ER

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult subjects must have noncancer chronic pain for at least six months on a daily basis,
Be prescribed opioids on a daily basis
Have an upper dose limit of daily opioids of 200 mg of morphine equivalents. This is because at doses greater than 200 mg daily, in the investigator's experience it is much more difficult to convert completely to another opioid compound within a week. Fentanyl and methadone users will not be specifically excluded unless their dosages fall outside this range.
Ages 21-70
Reported difficulty swallowing their opioid medication on the screening form at a level determined significant by the PI.
Having a mobile phone. A smart phone is not required to respond to the text messages.
Having Internet access to be able to respond to the emailed weekly surveys.
If sexually active and able to become pregnant, must agree to use an acceptable method of birth control (hormonal methods, barrier methods with spermicide, intrauterine device (IUD) or abstinence).
Only Pain Medicine Clinic patients may participate in this study

Exclusion Criteria:

Inability to understand the surveys and complete them.
Pregnancy
High risk for opioid addiction and/or abuse behaviors
Any condition, physical or mental, that in the investigator's judgment precludes optimal participation in the study procedures. This includes any documented current history of liver disease, renal insufficiency, delirium, alcohol use disorder, breast-feeding mothers, acute or severe asthma, chronic obstructive pulmonary disease requiring home oxygen, GI obstruction, biliary tract disease, pancreatitis, cardiac arrhythmia, bladder or urethral obstruction, adrenal insufficiency, psychosis, or taking medications which are potent inhibitors of the CYP3A4 enzyme (such as protease inhibitors, macrolide antibiotics, or antifungals).
Demonstration of abusive alcohol behavior. For women, this is more than 3 drinks on any single day or more than 7 drinks per week. For men, more than 4 drinks on any single day or more than 14 drinks per week.
Currently taking fentanyl or methadone
Exhibiting the following contraindicated conditions: (1) significant respiratory depression (2) acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (3) known or suspected gastrointestinal obstruction, including paralytic ileus (4) hypersensitivity (e.g. anaphylaxis) to oxycodone (5) patients with chronic pulmonary disease (6) elderly, cachet, or debilitated patients (7) patients with evidence of increased intracranial pressure, brain tumors, head injury, or impaired consciousness (8) patients with seizure disorders (9) pregnant and breastfeeding women, due to risks to the fetus/baby

Sites / Locations

UPMC Pain Medicine at Centre Commons

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xtampza ER (oxycodone) Treatment

Arm Description

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Outcomes

Primary Outcome Measures

Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours

Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.

Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days

Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.

Secondary Outcome Measures

Change in Pill Swallowing Difficulty Score

Pill swallowing difficulty will be measured via a 0-10 scale with 0 being "no trouble at all" and 10 being "the greatest difficulty possible." Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Not at all" and 5 being "Very much". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6).

Opioid Medication Satisfaction

Opioid medication satisfaction will be measured via a 0-10 scale with 0 being "not satisfied at all" and 10 being "completely satisfied." Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).

PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance

The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).

PROMIS Physical Function

The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being "Without any difficulty" and 1 being "Unable to do". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).

Patient Global Impression of Change (PGIC)

The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6).

Full Information

NCT ID

NCT03588806

First Posted

May 7, 2018

Last Updated

June 10, 2020

Sponsor

Ajay Wasan, MD, Msc

Collaborators

Collegium Pharmaceutical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03588806

Brief Title

Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

Official Title

Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Terminated

Why Stopped

Study halted permanently and will not resume; participants are no longer being examined or receiving intervention.

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ajay Wasan, MD, Msc

Collaborators

Collegium Pharmaceutical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Opioid Use, Deglutition

Keywords

Abuse-deterrent opioid drugs, Xtampza ER

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xtampza ER (oxycodone) Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Xtampza ER (oxycodone)

Intervention Description

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

Primary Outcome Measure Information:

Title

Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours

Description

Time Frame

Measured at baseline and at the end of the 6-week study

Title

Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days

Description

Time Frame

Measured at baseline and at the end of the 6-week study

Secondary Outcome Measure Information:

Title

Change in Pill Swallowing Difficulty Score

Description

Time Frame

Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.

Title

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

Description

Time Frame

Measured at baseline and at the end of the 6-week study

Title

Opioid Medication Satisfaction

Description

Time Frame

Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.

Title

PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance

Description

Time Frame

Measured at baseline and at the end of the 6-week study

Title

PROMIS Physical Function

Description

Time Frame

Measured at baseline and at the end of the 6-week study

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

Recorded in week 6.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult subjects must have noncancer chronic pain for at least six months on a daily basis, Be prescribed opioids on a daily basis Have an upper dose limit of daily opioids of 200 mg of morphine equivalents. This is because at doses greater than 200 mg daily, in the investigator's experience it is much more difficult to convert completely to another opioid compound within a week. Fentanyl and methadone users will not be specifically excluded unless their dosages fall outside this range. Ages 21-70 Reported difficulty swallowing their opioid medication on the screening form at a level determined significant by the PI. Having a mobile phone. A smart phone is not required to respond to the text messages. Having Internet access to be able to respond to the emailed weekly surveys. If sexually active and able to become pregnant, must agree to use an acceptable method of birth control (hormonal methods, barrier methods with spermicide, intrauterine device (IUD) or abstinence). Only Pain Medicine Clinic patients may participate in this study Exclusion Criteria: Inability to understand the surveys and complete them. Pregnancy High risk for opioid addiction and/or abuse behaviors Any condition, physical or mental, that in the investigator's judgment precludes optimal participation in the study procedures. This includes any documented current history of liver disease, renal insufficiency, delirium, alcohol use disorder, breast-feeding mothers, acute or severe asthma, chronic obstructive pulmonary disease requiring home oxygen, GI obstruction, biliary tract disease, pancreatitis, cardiac arrhythmia, bladder or urethral obstruction, adrenal insufficiency, psychosis, or taking medications which are potent inhibitors of the CYP3A4 enzyme (such as protease inhibitors, macrolide antibiotics, or antifungals). Demonstration of abusive alcohol behavior. For women, this is more than 3 drinks on any single day or more than 7 drinks per week. For men, more than 4 drinks on any single day or more than 14 drinks per week. Currently taking fentanyl or methadone Exhibiting the following contraindicated conditions: (1) significant respiratory depression (2) acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (3) known or suspected gastrointestinal obstruction, including paralytic ileus (4) hypersensitivity (e.g. anaphylaxis) to oxycodone (5) patients with chronic pulmonary disease (6) elderly, cachet, or debilitated patients (7) patients with evidence of increased intracranial pressure, brain tumors, head injury, or impaired consciousness (8) patients with seizure disorders (9) pregnant and breastfeeding women, due to risks to the fetus/baby

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajay D Wasan, MD, MSc

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Pain Medicine at Centre Commons

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26543509

Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

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