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Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration

Information source: Mallinckrodt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Hydromorphone Hydrochloride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mallinckrodt

Official(s) and/or principal investigator(s):
Richard Rauck, MD, Principal Investigator, Affiliation: Carolinas Pain Institute

Overall contact:
Lisa Sisk, Phone: 314-654-3524, Email: lisa.sisk@mallinckrodt.com


The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.

Clinical Details

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.

Detailed description: 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 concentrations.


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


Inclusion Criteria: 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. Exclusion Criteria: 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 visits. 9. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.

Locations and Contacts

Lisa Sisk, Phone: 314-654-3524, Email: lisa.sisk@mallinckrodt.com

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Richard L Rauck, MD
Richard L Rauck, MD, Principal Investigator
Additional Information

Starting date: June 2013
Last updated: June 5, 2015

Page last updated: August 23, 2015

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