Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration
Information source: Mallinckrodt
ClinicalTrials.gov processed this data on December 21, 2014
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Hydromorphone Hydrochloride (Drug)
Phase: Phase 3
Sponsored by: Mallinckrodt
Official(s) and/or principal investigator(s):
Richard Rauck, MD, Principal Investigator, Affiliation: Carolinas Pain Institute
Nicole Kelley, Phone: 314-654-7267, Email: firstname.lastname@example.org
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride
administered by intrathecal delivery.
Official title: A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone.
This is an open-label, single-arm safety study to evaluate the safety of hydromorphone
hydrochloride given by continuous intrathecal infusion using an implantable pump device.
This study will enroll both subjects on a current opioid intrathecal medication as well as
na´ve subjects now current on intrathecal opioid medications. All subjects currently on
intrathecal opioid treatment will be converted from their current intrathecal therapy to
intrathecal hydromorphone hydrochloride according to standard medical practice. After an
optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12
months or until discontinuation from the study. During this continuous dosing period, dose
adjustments (up or down) are permitted to manage pain or side effects provided a maximum
dose of 10 mg/day is not exceeded. Subjects will be assessed for pain intensity using a
VASPI instrument at each study visit.
Subjects will be evaluated for side effects and clinical complications associated with the
use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and
Minimum age: 18 Years.
Maximum age: 75 Years.
Subjects must meet all of the following criteria to be included:
1. Subjects must be at least 18 years of age and no more than 75 years old.
2. Clinically diagnosed with severe chronic pain for at least a 6-month period.
3. Subject is reasonably expected to benefit from intrathecal pain medication and has a
programmable implantable intrathecal pump or meets clinical criteria for implantation
of an intrathecal pump per Standard of Care.
4. Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting
narcotic prescriptions to the study medication prescribed by the investigator.
5. Subject must be cognitively intact and, in the opinion of the investigator, capable
of participation in the trial.
6. Female subjects of child-bearing potential must agree to use a medically acceptable
and effective double-barrier method of birth control.
7. Subjects who can receive an MRI if required by the study protocol.
8. Provides written Ethics Committee approved informed consent.
9. Willing to comply with all study procedures and requirements.
Subjects meeting any of the following criteria will be excluded:
1. Women who are pregnant or breast-feeding.
2. Subject has any known or suspected allergy to hydromorphone hydrochloride or to the
materials of the infusion pump or intrathecal catheter.
3. Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or
benzodiazepines, as defined by DSM-IV criteria, within the past year (physical
dependence on prescribed opioid analgesics is allowed but abuse of opioids according
to DSM-IV is not permitted, i. e. opioid addiction for recreational use).
4. Subjects who show signs of active systemic infection.
5. Subjects with a metastatic cancer to the spinal canal or a known central nervous
system contraindication to intrathecal therapy.
6. Subjects have a condition requiring diathermy procedures.
7. Subject has a life expectancy of less than 12 months.
8. Subjects who are unable or unwilling to return to all of the required follow-up
9. As a result of medical review and physical examination, the Investigator considers
the subject unfit for the study.
Locations and Contacts
Nicole Kelley, Phone: 314-654-7267, Email: email@example.com
Alabama Pain Center, Huntsville, Alabama 35801, United States; Recruiting
Leah Pinkerton, BSN, RN, Phone: 256-882-2003, Ext: 1300, Email: firstname.lastname@example.org
K. Dean Willis, MD, Principal Investigator
Center for Pain and Supportive Care, Phoenix, Arizona 85028, United States; Recruiting
Lisa Stearns, MD, Phone: 480-889-0180, Email: email@example.com
Krisstin Hammond, Phone: 480.516.0233
Lisa Stearns, MD, Principal Investigator
Neurovations, Napa, California 94558, United States; Recruiting
Eric Grigsby, MD, MBA, Phone: 707-252-9606, Email: firstname.lastname@example.org
Whitney Michiels, Phone: 707-252-9606, Email: email@example.com
Eric Grigsby, MD, MBA, Principal Investigator
National Pain Research Institute, LLC, Winter Park, Florida 32789, United States; Recruiting
Cherian K Sajan, MD, Phone: 407-622-5766, Email: firstname.lastname@example.org
Joan Cutillo, Phone: 407-622-5766, Email: email@example.com
Cherian K Sajan, MD, Principal Investigator
Millennium Pain Center, Bloomington, Illinois 61701, United States; Recruiting
Ramsin Benyamin, MD, Phone: 309-662-4321
Sarah Roberts, Phone: 309-662-4321, Email: firstname.lastname@example.org
Ramsin Benyamin, MD, Principal Investigator
Pain Care Associates, Bloomfield Hills, Michigan 48302, United States; Recruiting
Todd Lininger, MD, Phone: 248-751-7246, Email: email@example.com
Kelli Bocan, Phone: 248-751-7246, Ext: 421, Email: firstname.lastname@example.org
Todd Lininger, MD, Principal Investigator
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Michael Sikorsky, DO, Email: email@example.com
Cynthia Turzewski, RN, Phone: 248.898.1907, Email: Cynthia.Turzewski@beaumont.edu
Michael Sikorsky, DO, Principal Investigator
The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Richard L Rauck, MD
Richard L Rauck, MD, Principal Investigator
Pain Research of Oregon/Pain Consultants of Oregon, Eugene, Oregon 97401, United States; Recruiting
Donna M Morgan, MD, Phone: 541-684-9451, Email: DMorgan@pain-consultants.com
Chris Green, Phone: 541-684-9451, Email: CGreen@pain-consultants.com
Donna M Morgan, MD, Principal Investigator
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Marc Huntoon, MD, Phone: 615-322-6033, Email: firstname.lastname@example.org
Donna Nelson, RN, Phone: 615-343-9769, Email: email@example.com
Marc Huntoon, MD, Principal Investigator
Houston Pain Centers, Houston, Texas 77030, United States; Recruiting
Allen Burton, MD, Phone: 713-737-7246, Email: firstname.lastname@example.org
Erica N Butler, Phone: 713-973-7246, Email: email@example.com
Allen Burton, MD, Principal Investigator
The Center for Pain Relief Tri-State, Huntington, West Virginia 25702, United States; Recruiting
David Caraway, MD, PhD, Phone: 304-526-8384, Email: firstname.lastname@example.org
Kathy Clagg, RN, Phone: 304 526-8384, Email: email@example.com
David Caraway, MD, PhD, Principal Investigator
Starting date: June 2013
Last updated: December 1, 2014