Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

NCT03588806 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: PRO17040444
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use; Deglutition

Keywords

Abuse-deterrent opioid drugs; Xtampza ER

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (6)

• Change in Pill Swallowing Difficulty Score

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

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

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

• Opioid Medication Satisfaction

  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.

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

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

• PROMIS Physical Function

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

Study Arms (1)

Xtampza ER (oxycodone) Treatment

EXPERIMENTAL

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)

Interventions

Xtampza ER (oxycodone) DRUG

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

Xtampza ER (oxycodone) Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajay Wasan, MD, Msc: lead
• Collegium Pharmaceutical, Inc.: collaborator

Study Sites (1)

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (8)

• Fields J, Go JT, Schulze KS. Pill Properties that Cause Dysphagia and Treatment Failure. Curr Ther Res Clin Exp. 2015 Aug 20;77:79-82. doi: 10.1016/j.curtheres.2015.08.002. eCollection 2015 Dec.

  PMID: 26543509 BACKGROUND

• Engelhard E, Smith C, Vervoort S, Kroon F, Brinkman K, Nieuwkerk P, Reiss P, Geerlings S. Patients' willingness to take separate component antiretroviral therapy regimens for HIV in the Netherlands. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19536. doi: 10.7448/IAS.17.4.19536. eCollection 2014.

  PMID: 25394045 BACKGROUND

• Llorca PM. Discussion of prevalence and management of discomfort when swallowing pills: orodispersible tablets expand treatment options in patients with depression. Ther Deliv. 2011 May;2(5):611-22. doi: 10.4155/tde.11.32.

  PMID: 22833978 BACKGROUND

• Pergolizzi JV Jr, Taylor R Jr, Nalamachu S, Raffa RB, Carlson DR, Varanasi RK, Kopecky EA. Challenges of treating patients with chronic pain with dysphagia (CPD): physician and patient perspectives. Curr Med Res Opin. 2014 Feb;30(2):191-202. doi: 10.1185/03007995.2013.854197. Epub 2013 Oct 28.

  PMID: 24117419 BACKGROUND

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 BACKGROUND

• Wasan AD, Michna E, Edwards RR, Katz JN, Nedeljkovic SS, Dolman AJ, Janfaza D, Isaac Z, Jamison RN. Psychiatric Comorbidity Is Associated Prospectively with Diminished Opioid Analgesia and Increased Opioid Misuse in Patients with Chronic Low Back Pain. Anesthesiology. 2015 Oct;123(4):861-72. doi: 10.1097/ALN.0000000000000768.

  PMID: 26375824 BACKGROUND

• Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial. Pain. 2010 Sep;150(3):390-400. doi: 10.1016/j.pain.2010.02.033. Epub 2010 Mar 23.

  PMID: 20334973 BACKGROUND

• Wasan AD, Davar G, Jamison R. The association between negative affect and opioid analgesia in patients with discogenic low back pain. Pain. 2005 Oct;117(3):450-461. doi: 10.1016/j.pain.2005.08.006.

  PMID: 16154274 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ajay D. Wasan
• Organization: University of Pittsburgh

wasanad@upmc.edu

4126658030

Study Officials

• Ajay D Wasan, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: July 17, 2018
• Study Start: May 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 17, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)