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Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588806
Recruitment Status : Terminated (Study halted permanently and will not resume; participants are no longer being examined or receiving intervention.)
First Posted : July 17, 2018
Results First Posted : June 4, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Collegium Pharmaceutical, Inc.
Information provided by (Responsible Party):
Ajay Wasan, MD, Msc, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE July 17, 2018
Results First Submitted Date  ICMJE May 18, 2020
Results First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours [ Time Frame: Measured at baseline and at the end of the 6-week study ]
    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 [ Time Frame: Measured at baseline and at the end of the 6-week study ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • Change in Pill Swallowing Difficulty Score [ 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. ]
    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 [ Time Frame: Measured at baseline and at the end of the 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), 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 [ 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. ]
    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 [ Time Frame: Measured at baseline and at the end of the 6-week study ]
    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 [ Time Frame: Measured at baseline and at the end of the 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), 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) [ Time Frame: Recorded in week 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 at clinic visit 4 (week 6).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Official Title  ICMJE Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Pain
  • Opioid Use
  • Deglutition
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Xtampza ER (oxycodone)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 18, 2020)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
20
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03588806
Other Study ID Numbers  ICMJE PRO17040444
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ajay Wasan, MD, Msc, University of Pittsburgh
Study Sponsor  ICMJE Ajay Wasan, MD, Msc
Collaborators  ICMJE Collegium Pharmaceutical, Inc.
Investigators  ICMJE
Principal Investigator: Ajay D Wasan, MD, MSc University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP