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Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

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ClinicalTrials.gov Identifier: NCT03588806
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ajay Wasan, MD, Msc, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Use Deglutition Drug: Xtampza ER (oxycodone) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xtampza ER (oxycodone) Treatment
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.
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.




Primary Outcome Measures :
  1. Effect of Xtampza ER conversion on pain intensity in the last 24 hours [ Time Frame: Once a day for the entire 6-week study. ]
    The subject's pain intensity will be measured via a 0-10 scale with 0 being "no pain" and 10 being "the worst pain imaginable." Pain intensity will be recorded for the subject's current pain (pain now), and for the subject's average pain over the last 24 hours. Responses to daily pain questions will be summarized as weekly individual means, weekly individual standard deviation, change from baseline, and percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  2. Effect of Xtampza ER conversion on pain intensity in the last 7 days [ Time Frame: Once a week for the entire 6-week study. ]
    The subject's pain intensity will be measured via a 0-10 scale with 0 being "no pain" and 10 being "the worst pain imaginable." Once a week, the subject will be asked to rate their average pain over the last 7 days. Responses to weekly pain intensity questions will be summarized as change from baseline and percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.


Secondary Outcome Measures :
  1. Pill Swallowing Difficulty Questions [ Time Frame: Recorded once a week throughout the study. Week 1 covers current opioid medication, and weeks 2-6 cover Xtampza ER. ]
    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 raw weekly scores, as change from baseline, and as percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference [ Time Frame: Once a week for the entire 6-week study. ]
    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). Pain Interference T-Scores will be summarized as individual weekly scores, as change from baseline, and as percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  3. Opioid Medication Satisfaction [ Time Frame: Recorded in week 1 for current opioid medication and in weeks 3, 5 & 6 for Xtampza ER. ]
    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 raw weekly scores, as change from baseline, and as percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  4. PROMIS Depression, Anxiety, Satisfaction with Social Roles, Sleep Disturbance, and Fatigue [ Time Frame: Once a week for the entire 6-week study. ]
    The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), Sleep Disturbance (#17-20), and Fatigue (#13-16) 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). These T-Scores will be summarized as individual weekly scores, as change from baseline, and as percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  5. PROMIS Physical Function [ Time Frame: Once a week for the entire 6-week study. ]
    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). Physical Function T-Scores will be summarized as individual weekly scores, as change from baseline, and as percent change from baseline. As this is a small pilot study, it is not yet clear which summary measure will best reflect the results and allow the researchers to detect within-subject effects. The final summary measure will be selected at the discretion of the PI.

  6. Patient Global Impression of Change (PGIC) [ Time Frame: Recorded in weeks 5 and 6. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult subjects must have noncancer chronic pain for at least six months on a daily basis,
  2. Be prescribed opioids on a daily basis
  3. 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.
  4. Ages 21-70
  5. Reported difficulty swallowing their opioid medication on the screening form at a level determined significant by the PI.
  6. Having a mobile phone. A smart phone is not required to respond to the text messages.
  7. Having Internet access to be able to respond to the emailed weekly surveys.
  8. 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).
  9. Only Pain Medicine Clinic patients may participate in this study

Exclusion Criteria:

  1. Inability to understand the surveys and complete them.
  2. Pregnancy
  3. High risk for opioid addiction and/or abuse behaviors
  4. 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).
  5. 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.
  6. Currently taking fentanyl or methadone
  7. 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

Information from the National Library of Medicine

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): NCT03588806


Locations
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United States, Pennsylvania
UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Ajay Wasan, MD, Msc
Investigators
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Principal Investigator: Ajay D Wasan, MD, MSc University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Ajay Wasan, MD, Msc, University of Pittsburgh:
Informed Consent Form  [PDF] February 9, 2018


Publications:

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Responsible Party: Ajay Wasan, MD, Msc, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03588806     History of Changes
Other Study ID Numbers: PRO17040444
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ajay Wasan, MD, Msc, University of Pittsburgh:
Abuse-deterrent opioid drugs
Xtampza ER
Additional relevant MeSH terms:
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Oxycodone
Deglutition Disorders
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents