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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Mallinckrodt
Information provided by (Responsible Party):
Mallinckrodt Identifier:
First received: September 4, 2012
Last updated: December 1, 2015
Last verified: December 2015
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.

Condition Intervention Phase
Chronic Pain
Drug: Hydromorphone Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration

Resource links provided by NLM:

Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study. The patient status will be assessed by providing a VASPI score at each study visit. Subjects who drop out provide a VASPI assessment prior to discontinuation from the study.

Estimated Enrollment: 350
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
Other Names:
  • Hydromorphone
  • Opioid

Detailed Description:

This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study. During this continuous dosing period, dose adjustments (up or down) are permitted to manage pain or side effects provided a maximum dose of 10 mg/day is not exceeded. Subjects will be assessed for pain intensity using a VASPI instrument at each study visit.

Subjects will be evaluated for side effects and clinical complications associated with the use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and concentrations.


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

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.
  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 identifier: NCT01709747

Contact: Rachel Margulis 314-654-8275

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

Responsible Party: Mallinckrodt Identifier: NCT01709747     History of Changes
Other Study ID Numbers: CNS-HYD202US 
Study First Received: September 4, 2012
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Hydromorphone Hydrochloride
Chronic Pain
Implantable Pump

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on May 04, 2016