Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

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

Inclusion criteria

Subjects must meet all of the following criteria to be included:

• Subject must be at least 18 years of age and no more than 75 years old.
• Clinically diagnosed with chronic pain for at least a 6-month period.
• 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.
• Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
• Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
• Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
• Subjects with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy only.
• Subjects who are capable of receiving an MRI with or without contrast or CT myelogram, if required by the study protocol.
• Provides written Ethics Committee approved informed consent.
• Willing to comply with all study procedures and requirements..

Exclusion criteria

Subjects meeting any of the following criteria will be excluded:

• Women who are pregnant or are breast-feeding
• Subjects who have participated in an investigational drug or device trial within 4 weeks prior to enrollment.
• Subject has any known or suspected allergy to hydromorphone or to the materials of the infusion pump or intrathecal catheter.
• Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
• 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).
• Subjects who show signs of active systemic infection.
• Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
• Subject has a condition requiring diathermy procedures.
• Subject has a life expectancy of less than 12 months.
• 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.
• Subject is not considered to be medically or psychologically appropriate for pump implantation.
• Subjects who are unable or unwilling to return to all of the required follow-up visits.
• 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.
• As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
• 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.
• Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.