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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Mallinckrodt
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01709721
First received: August 24, 2012
Last updated: June 5, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Management of Chronic Pain
Drug: Hydromorphone Hydrochloride
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the proportion of subjects who are treatment failures during the double-blind randomized withdrawal period. A subject who experiences an increase of 20 mm or more points on a 100 mm VASPI, based on a 3-day average, or who experiences intolerable pain that requires intervention, will be considered a treatment failure


Secondary Outcome Measures:
  • Functionality based on a Brief Pain Inventory [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Patients ability to function and perform tasks without significant pain based on the BPI scale.


Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Subjects on hydromorphone hydrochloride for the duration of therapy.
Drug: Hydromorphone Hydrochloride
Subjects who meet criteria for randomization, will be randomized in a 1:1 ratio to either the active arm or control arm.
Other Names:
  • Hydromorphone
  • Opioid
Active Comparator: Titrated off therapy
Subjects on control
Drug: Hydromorphone Hydrochloride
Active Control Based on Dose Reduction

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Subject must be at least 18 years of age and no more than 75 years old.
  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. Subjects who are naïve to intrathecal therapy, may be enrolled 2-weeks after pump implantation.
  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. Subjects with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy only.
  8. Subjects who are capable of receiving an MRI with or without contrast or CT mylogram, 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:

Subjects meeting any of the following criteria will be excluded:

  1. Women who are pregnant or are breast-feeding
  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. Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
  5. 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).
  6. Subjects who show signs of active systemic infection.
  7. Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
  8. Subject has a condition requiring diathermy procedures.
  9. Subject has a life expectancy of less than 12 months.
  10. Subject cannot independently comprehend and participate in the required assessments, including responding to the VASPI, SF-MPQ, COWS, SOWS, BPI and PGIC measurement tools.
  11. Subject is not considered to be medically or psychologically appropriate for pump implantation.
  12. Subjects who are unable or unwilling to return to all of the required follow-up visits.
  13. 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.
  14. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
  15. 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.
  16. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709721

Contacts
Contact: Lisa Sisk 314-354-3524 lisa.sisk@mallinckrodt.com

Locations
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Richard Rauck, MD, FACP         
Principal Investigator: Richard L Rauck, MD         
Sponsors and Collaborators
Mallinckrodt
Investigators
Principal Investigator: Richard L Rauck, MD The Center for Clinical Research
  More Information

No publications provided

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01709721     History of Changes
Other Study ID Numbers: CNS-HYD201US
Study First Received: August 24, 2012
Last Updated: June 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Hydromorphone
Hydromorphone Hydrochloride
Pain Management
Non-narcotic analgesics

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Hydromorphone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015