Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydromorphone Hydrochloride; Programmable Implantable pump
Intervention description: Opioid for chronic pain; Device: Programmable Implantable pump
Programmable Implantable pump delivering intrathecal hydromorphone
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hydromorphone Hydrochloride; Hydromorphone; Pain; Chronic Pain; Implantable Pump; Pump; Intrathecal

Summary:

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

Eligibility criteria:

        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 Diagnostic and Statistical Manual of Mental Disorders,
             4th edition (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.