Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
Condition: Management of Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydromorphone Hydrochloride; Programmable Implantable pump
Intervention description: Opioid for chronic pain; Programmable Implantable pump delivering intrathecal hydromorphone
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hydromorphone; Hydromorphone Hydrochloride; Pain Management; Non-narcotic analgesics

Summary:

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

Eligibility 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 myelogram,
             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, Short-form McGill Pain Questionnaire (SF-MPQ),
             Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS),
             BPI and patient global impression of change (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.