Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
Information source: Mallinckrodt
ClinicalTrials.gov processed this data on December 21, 2014
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Management of Chronic Pain
Intervention: Hydromorphone Hydrochloride (Drug); Hydromorphone Hydrochloride (Drug)
Phase: Phase 3
Sponsored by: Mallinckrodt
Official(s) and/or principal investigator(s):
Richard L Rauck, MD, Principal Investigator, Affiliation: The Center for Clinical Research
Lisa Sisk, Phone: 314-354-3524, Email: firstname.lastname@example.org
The purpose of this study is to determine the safety and efficacy of hydromorphone
hydrochloride by intrathecal administration using a programmable implantable pump.
Official title: A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.
Secondary outcome: Functionality based on a Brief Pain Inventory
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and
Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a
Programmable Implantable Pump
Minimum age: 18 Years.
Maximum age: 75 Years.
Subjects must meet all of the following criteria to be included:
1. Subject must be at least 18 years of age and no more than 75 years old.
2. Clinically diagnosed with chronic pain for at least a 6-month period.
3. Subject is presently on intrathecal pain medication and has a SynchroMed II
Implantable pump or meets clinical criteria for implantation of a SynchroMed II
Implantable pump. Subjects who are naïve to intrathecal therapy, may be enrolled
2-weeks after pump implantation.
4. Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting
narcotic prescriptions to the study physician.
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 with existing SynchroMed II Implantable pumps and are reasonably expected to
benefit from intrathecal opioid therapy only.
8. Subjects who are capable of receiving an MRI with or without contrast or CT mylogram,
if required by the study protocol.
9. Provides written Ethics Committee approved informed consent.
10. 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 are breast-feeding
2. Subjects who have participated in an investigational drug or device trial within 4
weeks prior to enrollment.
3. Subject has any known or suspected allergy to hydromorphone or to the materials of
the infusion pump or intrathecal catheter.
4. Subject is scheduled for a pump or catheter replacement within 6 months of their
enrollment into the trial.
5. 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).
6. Subjects who show signs of active systemic infection.
7. Subjects with a metastatic cancer to the spinal canal or a known central nervous
system contraindication to intrathecal therapy.
8. Subject has a condition requiring diathermy procedures.
9. Subject has a life expectancy of less than 12 months.
10. Subject cannot independently comprehend and participate in the required assessments,
including responding to the VASPI, SF-MPQ, COWS, SOWS, BPI and PGIC measurement
11. Subject is not considered to be medically or psychologically appropriate for pump
12. Subjects who are unable or unwilling to return to all of the required follow-up
13. Subjects with active implanted devices such as pacemakers, defibrillators, and
cochlear implants or other medical device use, if in the opinion of the investigator
the device would interfere with the ability to perform an MRI or CT myelogram.
14. As a result of medical review and physical examination, the Investigator considers
the subject unfit for the study.
15. Pain located above the shoulders in the head or neck region (e. g. trigeminal
neuralgia), central pain syndromes or any other condition in which it is judged to be
unlikely that the subject would benefit from intrathecal administration of the drug
16. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.
Locations and Contacts
Lisa Sisk, Phone: 314-354-3524, 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
Advocate Healthcare, Normal, Illinois 61761, United States; Not yet recruiting
Ramsin Benyamin, MD
Ramsin Benyamin, MD, Principal Investigator
Pain Care Associates, Bloomfield Hills, Michigan 48302, United States; Recruiting
Todd Lininger, MD, Phone: 248-751-7246, Email: firstname.lastname@example.org
Kelli Bocan, Phone: 248-751-7246, Ext: 421, Email: email@example.com
Todd Lininger, MD, Principal Investigator
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Michael Sikorsky, DO, Email: firstname.lastname@example.org
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 Rauck, MD, FACP
Richard L Rauck, MD, Principal Investigator
Nagy Mekhail, Cleveland, Ohio 44195, United States; Recruiting
Hani Yousef, Phone: 216-636-1484, Email: email@example.com
Nagy Mekhail, MD, Principal Investigator
Moss Rehab, Elkins Park, Pennsylvania 19027, United States; Recruiting
Michael Saulino, MD, PhD, Phone: 215-663-6607, Email: firstname.lastname@example.org
Marianne Pedicone, RN, BA, CRRN, Phone: 215-663-6112, Email: email@example.com
Michael Saulino, MD, PhD, 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: February 2013
Last updated: November 18, 2014