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

Completed · Phase 3

Conditions studied: Chronic Pain

In brief

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

Key facts

Study ID

NCT01709747

Run by

Piramal Critical Care, Ltd.

People needed

364

Starts

2013-06-01

Expected to finish

2018-02-01

Last updated by the study team

2021-08-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be included:
• Subjects must be at least 18 years of age and no more than 75 years old.
• Clinically diagnosed with severe chronic pain for at least a 6-month period.
• 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.
• Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
• 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 who can receive an MRI if required by the study protocol.
• Provides written Ethics Committee approved informed consent.
• Willing to comply with all study procedures and requirements.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded:
• Women who are pregnant or breast-feeding.
• Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
• 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).
• 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.
• Subjects have a condition requiring diathermy procedures.
• Subject has a life expectancy of less than 12 months.
• Subjects who are unable or unwilling to return to all of the required follow-up visits.
• As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.

Where it is running

• The Center for Clinical Research — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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