Chronic Pain | Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
Chronic Pain research study
What is the primary objective of this study?
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Hydromorphone HydrochlorideOpioid for chronic pain
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Hydromorphone HydrochlorideHydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Active, not recruiting
Start Date: June 2013
Completed Date: September 2017
Phase: Phase 3
Primary Outcome: Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone.
Study sponsors, principal investigator, and references
Principal Investigator: Richard Rauck, MD
Lead Sponsor: Mallinckrodt