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Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump

Information source: Mallinckrodt
ClinicalTrials.gov processed this data on November 27, 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

Status: Recruiting

Sponsored by: Mallinckrodt

Official(s) and/or principal investigator(s):
Richard L Rauck, MD, Principal Investigator, Affiliation: The Center for Clinical Research

Overall contact:
Lisa Sisk, Phone: 314-354-3524, Email: lisa.sisk@mallinckrodt.com

Summary

The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.

Clinical Details

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

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 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.. Exclusion Criteria: 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 tools. 11. Subject is not considered to be medically or psychologically appropriate for pump implantation. 12. Subjects who are unable or unwilling to return to all of the required follow-up visits. 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 product. 16. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.

Locations and Contacts

Lisa Sisk, Phone: 314-354-3524, Email: lisa.sisk@mallinckrodt.com

Alabama Pain Center, Huntsville, Alabama 35801, United States; Recruiting
Leah Pinkerton, BSN, RN, Phone: 256-882-2003, Ext: 1300, Email: lpinkerton@alabamapaincenter.com
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: ljstearns@yahoo.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: eg@neurovations.com
Whitney Michiels, Phone: 707-252-9606, Email: whitney@neurovations.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: csajan@natpain.com
Joan Cutillo, Phone: 407-622-5766, Email: jcutillo@natpain.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: telininger@gmail.com
Kelli Bocan, Phone: 248-751-7246, Ext: 421, Email: kbocan@npcmi.com
Todd Lininger, MD, Principal Investigator

William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Michael Sikorsky, DO, Email: sikorskymsu@yahoo.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 Rauck, MD, FACP
Richard L Rauck, MD, Principal Investigator

Nagy Mekhail, Cleveland, Ohio 44195, United States; Recruiting
Hani Yousef, Phone: 216-636-1484, Email: yousefh@ccf.org
Nagy Mekhail, MD, Principal Investigator

Moss Rehab, Elkins Park, Pennsylvania 19027, United States; Recruiting
Michael Saulino, MD, PhD, Phone: 215-663-6607, Email: docsaulino@msn.com
Marianne Pedicone, RN, BA, CRRN, Phone: 215-663-6112, Email: pedicone007@comcast.net
Michael Saulino, MD, PhD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Marc Huntoon, MD, Phone: 615-322-6033, Email: marc.huntoon@vanderbilt.edu
Donna Nelson, RN, Phone: 615-343-9769, Email: donna.nelson@vanderbilt.edu
Marc Huntoon, MD, Principal Investigator

Houston Pain Centers, Houston, Texas 77030, United States; Recruiting
Allen Burton, MD, Phone: 713-737-7246, Email: awburtonmd@gmail.com
Erica N Butler, Phone: 713-973-7246, Email: ebutler@houstonpainassociates.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: carawaymd@aol.com
Kathy Clagg, RN, Phone: 304 526-8384, Email: kclagg@st-marys.org
David Caraway, MD, PhD, Principal Investigator

Additional Information

Starting date: February 2013
Last updated: November 18, 2014

Page last updated: November 27, 2014

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