NCT03588806

Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

Terminated Phase 4 Results posted Last updated 17 June 2020

What this trial tests

Phase 4 trial testing Xtampza ER (oxycodone) in Chronic Pain in 11 participants. Terminated before completion.

Timeline

1 May 2018

Primary endpoint
31 July 2019

31 October 2019

Quick facts

Lead sponsor	Ajay Wasan, MD, Msc
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	11
Start date	1 May 2018
Primary completion	31 July 2019
Estimated completion	31 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Xtampza ER (oxycodone) — full drug profile →

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Opioid Use — all drugs for Opioid Use →
• Deglutition — all drugs for Deglutition →

Sponsor

Ajay Wasan, MD, Msc — full company profile →

Who can join

Adults 21 to 65, any sex, with Chronic Pain or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	12.5	± 31.5

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

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	9.3	± 30

Change in Pill Swallowing Difficulty Score Secondary · 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).

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	-5.7	± 2.6

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

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	-3.6	± 8.2

Opioid Medication Satisfaction Secondary · 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).

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	2.8	± 4.0

PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance Secondary · 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 c

Depression

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	-0.4	± 7.3

Anxiety

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	-1.7	± 6.1

Satisfaction with Social Roles

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	1.1	± 4.9

Sleep Disturbance

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	-3.7	± 6.2

PROMIS Physical Function Secondary · 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).

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	0.7	± 5.0

Patient Global Impression of Change (PGIC) Secondary · 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).

Group	Value	95% CI
Xtampza ER (Oxycodone) Treatment	1.2	± 1.1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use of a Long-Acting Opioid Microsphere Formulation to Overcome Difficulties in Swallowing Pain Medication.
   Anderson N, Gillman AG, Wasan AD. · · 2020 · PMID 32440201 · DOI 10.2147/jpr.s249592