Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump

Condition(s) targeted: Management of Chronic Pain

Intervention: Hydromorphone Hydrochloride (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: CNS Therapeutics

Official(s) and/or principal investigator(s):
Richard L Rauck, MD, Principal Investigator, Affiliation: The Center for Clinical Research

Overall contact:
Richard E Lowenthal, MSc, Phone: 858-335-1300, Email: richard@pacificlinkconsulting.com

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.

Secondary outcome: Functionality based on a Brief Pain Inventory

Detailed description: 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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Subject must be at least 18 years of age and no more than 75 years old. of the following criteria to be included:

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.

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. Patients with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy.

8. Subjects who are capable of receiving an MRI 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:

1. Women who are pregnant or are breast-feeding of the following criteria will be excluded:

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. 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. Subject has a condition requiring diathermy procedures.

7. Subject has a life expectancy of less than 12 months.

8. Subject cannot independently comprehend and participate in the required assessments, including responding to the VASPI, SF-MPQ, COWS, BPI and PGIC measurement tools.

9. Subject is not considered to be medically or psychologically appropriate for pump implantation.

10. 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 function of the implantable intrathecal pump.

11. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.

12. 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 patient would benefit from intrathecal administration of the drug product.

13. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.

Richard E Lowenthal, MSc, Phone: 858-335-1300, Email: richard@pacificlinkconsulting.com

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Not yet recruiting
Richard Rauck, MD, FACP
Richard L Rauck, MD, Principal Investigator

Starting date: December 2012
Last updated: October 17, 2012